Fecal Immunochemical Test Test Research Articles

Adherence to follow-up and resource use after abnormal FIT-screening: Evaluation of the Danish colorectal cancer screening program.

Background and study aims The effectiveness of colorectal cancer screening programs depends on adherence to surveillance protocols for screening-positive individuals. We evaluated adherence in the Danish population-based screening program and estimated the volume of diagnostic resources required to achieve this adherence. Patients and methods In this register- and population-based study, we included individuals with a positive fecal immunochemical test (FIT) screening from 2014 to 2017 and followed them until mid-2022. All endoscopic, imaging, and surgical procedures performed at public and private hospitals were identified. Adherence to national protocols was reported in terms of proportions and timeliness. Use of diagnostic and surveillance procedures was estimated during a 4-year post-screening period. Results Among 82,221 individuals with a positive FIT test, 84% had a baseline colonoscopy within 1 month. After removal of intermediate or high-risk adenomas, 12% and 6%, respectively, did not have any follow-up. Only ~50% had timely surveillance. Approximately 10% to 20%, depending on their referral diagnosis, did not have a second surveillance colonoscopy. In addition, 12% with a negative colonoscopy had a second colonoscopy within 4 years. Conclusions High adherence to baseline colonoscopy after positive FIT-screening is followed by lower adherence throughout the adenoma surveillance program. Better adherence to the guidelines could potentially improve the effectiveness and efficiency of the screening program.

Introducing Colorectal Cancer Screening in Romania - Preliminary Results from the Regional Pilot Programs (ROCCAS).

Colorectal cancer (CRC) is the third cause of cancer-related death worldwide. Screening programs can reduce CRC mortality rates by up to 60%. In line with the European Union recommendations, Romania started the first four regional pilot screening programs in 2020 (the ROCCAS II projects). This study reports the interim screening performance indicators. People aged 50 to 74 years were invited to the screening program. General practitioners (GPs) evaluated CRC risk based on a survey. High-risk or symptomatic individuals were referred directly to colonoscopy. The average risk participants received a fecal immunochemical test (FIT). Positive cases were invited to colonoscopy. Three regions were screened using the OC-SENSOR® (South-Muntenia, Bucharest-Ilfov, South-East) and one region (South-West) used the FOB GOLD®. The data was collected in the ROCCAS screening electronic registry. The following FIT parameters were evaluated: rates of return, invalidity, positivity, and colonoscopy acceptance rate according to age group, gender, region of provenience, and vulnerability status. We included all cases screened between January 1, 2022 and September 30, 2023. In total, 168,958 people received the FIT test within the projects. The global FIT return rate was 90%. Factors associated with a higher return rate were female gender (90.77% vs 88.83%, p<0.0001), vulnerable status (91.23% vs 88.83%; p<0.00001), and rural residence (91.84% vs 88.42%, p<0.00001). The overall positivity rate was 5.75%. It was higher in males (7.64% vs 4.57% in females, p<0.00001) and progressively increased with the age group. The total invalid FIT rate was 5.87%, significantly lower for OC-SENSOR® (2.24%) than for the FOB GOLD® (13.6%). The overall acceptability rate for colonoscopy was 51.3%. According to our preliminary data, GP's participation in the pilot programs ensured adequate adherence to screening through FIT. The rate for FIT return and positivity were acceptable for both tests, while the invalid rate was much higher in FOB GOLD® compared to the OC-SENSOR®. Moreover, colonoscopy acceptance needs to be improved. Our preliminary analysis revealed the screening performance indicators meet the EU recommendations and fulfill the premises for national-level expansion of the program starting in 2024.

The Diagnostic Accuracy (DA) of ColonView Fecal Immunochemical Test (FIT) in Detecting Colorectal Adenoma (CRA) Can Be Improved by the Diagnostic Models (DM) that Include Triage and Risk Features of CRA.

This study assessed whether the diagnostic accuracy (DA) of ColonView (CV) fecal immunochemical test (FIT) in detecting colorectal adenoma (CRA) can be improved by the diagnostic models (DM) that include triage and risk features of CRA. A total of 5,090 participants of colorectal neoplasia (CRN) screening were recruited prospectively between January 2014 and December 2016. The CRN cohort of 486 patients included 222 CRA patients and 264 non-CRA patients of whom three consecutive fecal samples were analyzed by two fecal occult blood (FOB) assays (CV FIT test, HemoccultSENSA test). Hierarchical multilevel logistic models were used to test the DA of CV test and DMs, visualised as hierarchical summary receiving operating characteristic (HSROC) curves. In conventional receiving operating characteristic (ROC) analysis, the area under the curve (AUC) values of the age, height, weight, and body mass index (BMI) were 0.60, 0.57, 0.54, and 0.51, respectively. The AUC values for different DMs ranged from 0.69 (for DM without triage I/II and SENSA), and the highest AUC value of 0.70 was reached for DM with all variables included. In HSROC analysis, the AUC values for i) lowR variables, ii) highR variables, and ii) DMs were as follows: i) AUC=0.506, ii) AUC=0.566 and iii) AUC=0.732. The differences in AUC values were: between i) and ii) p=0.008; between i) and iii) p<0.0001; between ii) and iii) p<0.0001. The results demonstrated that DMs, particularly those including risk factors, significantly improved the DA of the CV FIT test in detecting CRA compared to traditional low-risk (lowR) and high-risk (highR) features alone. This study provides novel evidence supporting the enhanced diagnostic performance of DMs in combination with CV FIT testing for the detection of CRA.

Abstract C122: Patient perspectives on factors influencing repeat colorectal cancer screening in a Federally Qualified Health Center

Abstract Background. The life-saving benefits of colorectal cancer (CRC) screening can be maximized only if screening is completed at recommended intervals. The fecal immunochemical test (FIT), an inexpensive stool-based test recommended yearly, is the primary screening modality in many Federally Qualified Health Centers (FQHCs) and remains underutilized. To inform system interventions, we sought to identify patient perspectives on factors that influence the likelihood of repeated FIT screening over time in a large FQHC. Methods. Between September 2022 and March 2023, we conducted semi-structured interviews with patients who were due for FIT screening and completed at least one prior FIT test at a large FQHC that serves a primarily Latino population in Los Angeles County. Our interview guide explored patients’ perceived barriers and facilitators to repeat FIT over time and experiences with FIT clinic processes of care. Audio-recorded interviews were conducted in patients’ preferred language (English or Spanish), transcribed, and translated. Transcripts were coded using ATLAS.ti, and themes were summarized. Results. Among 17 interview participants, the majority were female (82%), Latino (94%), and Spanish-speaking (88%). The median age was 57 years (range 52-70), and 41% had an 8th grade education or less. Interviews revealed that patient, family, and provider/system factors influenced receipt of sequential rounds of annual FIT CRC screening. At the patient level, perceived importance of disease prevention and early detection on the part of patients facilitated proactive engagement in regular screening. Additionally, many patients thought the process of FIT completion and return was easy, although some patients did express low confidence in stool sample collection and time and work constraints impeding in-person FIT return. Another recurrent theme was motivation from family, both direct support (assistance with FIT completion and transportation to clinic) and indirect motivation (an intrinsic desire to stay healthy for family). At the provider/system level, language discordance hindered communication with providers, and in-language FIT instructions and availability of bilingual staff to translate were identified as facilitators. Patient suggestions to improve FIT completion included client text and letter reminders when due for CRC screening; print education that underscores the purpose of screening; and appointment consolidation for cancer and other preventive care screenings. Conclusion. Interventions to improve regular FIT-based CRC screening may benefit from emphasizing the importance of early detection; improving patient knowledge and confidence in how to perform stool sample collection; family support; and language-concordant staff and resources for multi-lingual and medically underserved populations. Citation Format: Narissa J. Nonzee, Beth A. Glenn, Debra Rosen, Genesis Sandoval, Diana Trujillo, Folasade P. May, Alison K. Herrmann, Christine Park, Alicia Lwin, Joanna Quintanilla, Jessica Tuan, Lauren Cai, Roshan Bastani. Patient perspectives on factors influencing repeat colorectal cancer screening in a Federally Qualified Health Center [abstract]. In: Proceedings of the 16th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2023 Sep 29-Oct 2;Orlando, FL. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2023;32(12 Suppl):Abstract nr C122.

Triage Process at Endoscopy With ColonView Fecal Immunochemical Test (FIT) Will Enhance Diagnostic Accuracy (DA) of Colorectal Cancer Screening.

This study assessed the diagnostic accuracy (DA) of the predictive features of colorectal cancer (CRC, predictCRC), triage process (triage), and ColonView (CV) fecal immunochemical test (FIT) in a CRC screening setting. The diagnostic score models (DMs) including predictCRC with triage and CV test were also calculated. The study cohort of 544 patients included 58 CRC patients and 486 non-CRC patients who submitted three consecutive fecal samples for analysis, by two fecal occult blood (FOB) assays (CV FIT test, HemoccultSENSA test). Hierarchical multilevel logistic models were used to test the DA (for CRC) of each item of predictCRC (with triage I and II) and DMs, visualized as hierarchical summary receiving operating characteristic (HSROC) curves. The DA of the predictCRC location of neoplasm (Loc), triage I, and triage II showed 49%, 41%, and 93% sensitivity (Se), and 70%, 99.5%, and 88% specificity (Sp), respectively. The PPV+ of triage I (92%) was higher than that of Loc (22%) or triage II test (45%). In the conventional receiver operating characteristic (ROC) analysis, the area under the curve (AUC) values for the different DMs ranged from 0.880 (for DM without triage I and II), whereas the highest AUC value of 0.960 was reached for DM with triage I and II included in the formula. In the HSROC analysis, the AUC values were as follows: i) with all predictCRCs, AUC=0.717 and ii) with DMs, AUC=0.937. In the roccomp analysis, the difference in AUC values between i) and ii) was statistically significant (p<0.0001). In the detection of CRC, the DA of the new DMs with triage was far superior to that of DMs without triage. This is the first study to report evidence of improved DA in the detection of CRC using DMs including predictCRC with triage and CV FIT test.

Impact of Various Risk Factors on the Positive Fecal Immunochemical Test for Colorectal Cancer in the Iranian Population.

Background: Colorectal cancer (CRC) is the most prevalent cancer with high mortality worldwide. We aimed to evaluate the incidence of CRC based on the positive fecal immunochemical test (FIT) result in the Iranian population. Methods: The present study was conducted on the health assessment data recorded in the SINA (Integrated Health Information System) in 2018 and 2019 from individuals who had participated in the national program, including asymptomatic people aged 50-69 years or had risk factors of CRC such as family or past personal history of CRC as well as symptomatic individuals, for the early detection and prevention of CRC in Mashhad, Iran. Results: The study participants included 140,463 eligible individuals, of whom 8258 (5.88%) and 145 (2.21%) were positive for FIT and diagnosed with colon cancer, respectively. Unfortunately, only 654 people had undergone colonoscopy. Our results indicated that age, fast food intake (≥two units per day), family history of CRC in first or second-degree relatives, some gastrointestinal diseases such as inflammatory bowel disease (IBD) and CRC, as well as bleeding per anus, constipation, abdominal cramp, and losing body weight were associated with increased risk of positive FIT. However, some other factors, including having a hard job, physical activity, and Iranian nationality (compared to non-Iranians), were associated with a low risk of positive FIT screening tests for CRC. Conclusion: A high number of high-risk persons in Mashhad were positive for the FIT test in 2018-2019, and many of them were diagnosed with CRC, according to the colonoscopy results. Therefore, screening is highly recommended as the first step in the early detection of CRC.

Colorectal Cancer Fast Tracks: Cancer Yield and the Predictive Value of Entry Criteria.

Fast-track pathways for diagnosing colorectal cancer (CRC) have been implemented in several European countries. In Sweden, a substantial number of CRC are diagnosed via the Swedish Standardized Course of Care for colorectal cancer (SCC-CRC). We evaluated the SCC-CRC in terms of CRC yield, and predictive values and odds ratios (OR) for the entry criteria. We retrospectively analyzed all 2539 patients referred for SCC-CRC colonoscopy between September 2016 and December 2020. Entry criteria and colonoscopy outcomes were analyzed. CRC yield was 16.4%. Highest positive predictive values (PPVs) were seen for abnormal radiology (PPV 30.5%, OR 4.7 (95% CI 3.4-6.4) p < 0.001), abnormal rectal examination (PPV 28%, OR 3.6 (95% CI 2.7-4.8) p < 0.001), and anemia (PPV 24.8%, OR 2.2 (95% CI 1.5-3.1) p < 0.001). Some entry criteria showed no significant risk increase, i.e., visible blood in stool/rectal bleeding, change in bowel habits, and the combination of changed bowel habits plus anemia. A positive fecal immunochemical test (FIT), although not part of the SCC-CRC, showed the highest OR: 9.9 (95% CI 4.5-21.7) p < 0.001) and PPV of 18.8%. CRC yield from the SCC-CRC is slightly higher compared to other European fast tracks. A number of entry criteria showed no benefit towards assessing CRC risk. FIT testing should be included in CRC fast tracks to increase diagnostic efficacy.

ThTP4.6 Which FIT level is fit for purpose?

Abstract Aims To assess the diagnostic performance of faecal immunochemical test (FIT) in patients referred under the two week-wait (2WW) pathway and to test colorectal cancer (CRC) detection thresholds. Methods All patients referred under the 2WW pathway for a study period of 2 months were identified; referring symptoms, FIT levels, investigations and final diagnosis were collected via the electronic patient records. Exclusion criteria were patients who were not under the 2WW pathway, patients without FIT, those that declined or unfit for further investigations. Data was anonymized and analysed using the SPSS software. Results 438 patients were referred to the colorectal team during the study period, 335 patients (157 males and 178 females) met the inclusion criteria, age range 25-93 years, mean age 69.33 years (SD 12.66). 14 patients had a final diagnosis of colorectal cancer. All 14 patients had a FIT &amp;gt;6.9 (p 0.012), that was also the case with a FIT of 10 and above (p 0.002) which had a stronger association, FIT test 11 and above, 15 and above and 20 and above being the positive threshold detected 13 of 14 patients with CRC with a p value 0.008, 0.002 and 0.001 respectively. Conclusions Our data shows that a FIT threshold of 10 and above detected all patients with CRC and even a slight increase of the threshold to 11 missed 7.1% (1/14) of patients with CRC. Hence patients with ‘slightly positive FIT’ should be considered for further investigations if appropriate.

Cost-effectiveness of ColoSTAT for primary colorectal cancer screening in the United States.

e15525 Background: Colorectal cancer (CRC) screening is at the cornerstone of strategies for reducing the mortality, healthcare and societal cost burden of CRC, the third most common cancer in the United States (US). ColoSTAT immunoassay is a simple, highly accurate, minimally invasive blood-based screening test for CRC that will be launched in the US market. Using a de novo decision analytic model, we compared the health benefits and cost-effectiveness of CRC screening with ColoSTAT with current screening offered by private insurers assuming a 5-yearly colonoscopy (COL) or biennial fecal immunochemical test (FIT) for the US population. Methods: For the three screening strategies, the expected number of CRC cases detected, and total screening program cost were estimated using a decision-analytic model based on: published CRC incidence in the US, tests performance characteristics, adherence rates to screening (61% for COL; 46% for FIT) and to diagnostic assessment via COL after a positive FIT or ColoSTAT test (80.4%). The gain in quality-adjusted life year (QALY) associated with every CRC case detected through screening, and confirmed by diagnostic assessment, was estimated by linking US-specific estimates of: CRC deaths by age-subgroups, life expectancies at the time of CRC death, quality of life projections for the general population and reduction in CRC mortality associated with screening. Healthcare cost savings associated with every CRC case detected through screening were estimated based on the distribution of CRC across disease stages by diagnosis method (screening versus symptomatically) and stage-specific CRC treatment costs. Results: Biennial screening with ColoSTAT, compared with 5-yearly COL screening offered by private insurers, is estimated to generate cost savings on screening programs of around $40 million per 100,000 people of screening age (PoSA) per one-off screening. When scaled up to the total US population within screening age covered by private insurance (66%), the estimated cost savings with ColoSTAT exceed $30 billion per one-off screening. The reduction in the number of CRC cases detected would generate a modest loss of 58 discounted QALYs per 100,000 people, that could be mitigated if ColoSTAT were to boost screening uptake. In the context of government-sponsored screening programs, replacing FIT with ColoSTAT is estimated to increase the number of CRC cases detected via screening by 9% (to 50 cases per 100,000 PoSA), assuming an unchanged screening uptake of 46%. At the commonly used value of $100,000 per QALY, this would equate to a discounted benefit of $834,820 per 100,000 PoSA per one-off screening. Conclusions: CRC screening with ColoSTAT as an alternative to COL could result in multi-billion-dollar cost savings to US private insurers while still detecting most CRC cases and generate population-health gains if used as an alternative to FIT in government-sponsored screening programs.

Analysis of patients at the Memphis VA Medical Center with positive FIT testing and incomplete GI evaluation during the COVID-19 pandemic.

e15542 Background: In 2020, colorectal cancer was the second leading cause of cancer death in the United States 1. In March 2020, the COVID pandemic began which led to widespread disparities in health care, such as surveillance colonoscopies 2. A Veterans Health Administration large data review revealed completion rates of colonoscopy for high risk individuals, including positive fecal immunochemical test (FIT) to be unchanged pre-pandemic and during the pandemic at 27% vs 26.5% 3. Another study reports a non-VA population completion rate within 360 days pre-COVID compared to COVID was 53.9% vs 44% 4. This research sought to analyze data through a retrospective chart review from the Memphis VA Medical Center, the timing of screening colonoscopies after a positive FIT and reasons for delay in obtaining these. Thereby, evaluating effectiveness in completing the procedures and change effected by the COVID pandemic. Methods: A retrospective cohort study designed to detect rates of completed colonoscopy during and before the COVID pandemic after a positive FIT. Records were reviewed of all positive FIT from 2 specified time frames at the Memphis VA to evaluate completion of colonoscopy after a positive FIT. The charts of 157 VA patients with positive FIT during the pandemic were compared to the charts of 115 VA patients with positive FIT pre-pandemic for colonoscopy completion, evaluating both completion rates within 180 days and chart identified reasons for lack of completion. Both community (CITC) and VA procedures for veterans were included. One tailed Fisher’s exact test was applied to calculate the completion rate difference. Results: Overall completion rate of colonoscopy was 46% in the pre-COVID and rose to 56% in the COVID period [p-value &lt; .05 (.0665)]. Percentage of timely completion ( &lt; 180 days) was 26% pre-COVID, compared to 47% during COVID. Percentage of delay ( &gt; 180 days) in pre-Covid was 74%, compared to 53% during COVID. [p-value &lt; .05 (.0004)]. Reasons for delay both pre-COVID and during COVID are listed below. Conclusions: It can be concluded that there is a statistically significant increase in timely colonoscopy completion during the studied COVID period when compared to the pre-COVID period. The total completion rate was higher at our institution than in the literature, likely due to our inclusion of community colonoscopies and our aggressive case management system. A common reason for delay in all groups was delay/lack of referral. This cause for delay should be improved with additional steps in our case management policy. [Table: see text]

Costs and outcomes of colorectal cancer screening program in Isfahan, Iran

BackgroundColorectal cancer is one of the most prevalent gastrointestinal cancers in Iran i.e., the fourth and the second prevalent cancer among Iranian males and females, respectively. A routine screening program is effective in the early detection of disease which can reduce the cancer burden both for individuals and society. In 2015, Iran’s Package of Essential Non- communicable Diseases program had been piloted in Shahreza city in Isfahan province. Colorectal cancer screening for the population aged 50–70 was a part of this program. So far, there was no study about the cost and outcomes of that program. Thus, this study aimed to analyze the costs and outcomes of colorectal cancer screening done from 2016 to 2019 in Shahreza.MethodsThis cost-outcome description study used the data of 19,392 individuals who were 50–70 years old experienced a fecal immunochemical test (FIT) and had an electronic health record. All direct costs including personnel, building space, equipment, training, etc. were extracted from the financial documents existing in the Isfahan province Health Center. The outcome was defined as positive FIT, detection of adenoma or malignancy as recorded in the E-integrated health system.ResultsThe results of this study indicated that the direct costs of the colorectal cancer screening program during the years 2016–2019 were 7,368,707,574 Rials (321,029 PPP$) in Shahreza, Isfahan province. These costs resulted in identifying 821 people with a positive FIT test, of those 367 individuals were undergone colonoscopy. Of whom 8 cases of colorectal cancer, and 151 cases with polyps were diagnosed.ConclusionThis study showed that by paying a small amount of 320 thousand international dollars we could prevent 151 cases of polyps to be progressed to colorectal cancer,resulting in a significant reduction in colorectal cancer incidence.

Abstract A112: A longitudinal evaluation of repeat colorectal cancer screening in a Federally Qualified Health Center (FQHC)

Abstract Background: Colorectal cancer (CRC) can be detected early or prevented through screening at recommended intervals. Fecal immunochemical testing (FIT), an inexpensive stool-based screening test, is the primary screening modality in low-resource health care settings, including Federally Qualified Health Centers (FQHCs). However, to maximize its life saving benefit, FIT screening must be completed annually (repeat screening), per guidelines. In FQHCs, only about 40% of eligible patients are up-to-date on CRC screening at a given time. Less is known about completion of repeat FIT over time in this setting. Therefore, UCLA partnered with Northeast Valley Health Corporation (NEVHC), a large multi-site FQHC serving predominantly low-income Latinos, to assess repeat FIT rates and factors that contribute to repeat FIT over a 5-year follow-up period. Methods: We performed a retrospective cohort study among NEVHC patients who completed a FIT test in 2013 and examined CRC screening completion over the subsequent 5 years (2014-2018). The study was conducted in eight comprehensive primary care sites at NEVHC. Our cohort included patients ages 50-70 years with a normal index FIT in 2013 and who were active NEVHC patients during the subsequent 5-year follow-up period. Using electronic medical record and administrative data, we identified that only one patient completed five rounds of screening at yearly intervals, as recommended, and thus calculated “repeat FIT” rate as the proportion of patients who completed at least 3 total FIT tests or a colonoscopy (i.e., index FIT and 2 additional FIT tests or colonoscopy) over the 6-year study period (2013-2018). We also performed bivariate analyses to evaluate factors associated with repeat FIT completion. Results: Among the 771 patients included in our sample, the average age at index FIT was 57 years. The majority of patients were Latino (83%, n=638) and spoke Spanish as their primary language (76%, n=588), and 43% (n=330) were insured through Medicaid, Medicare, California’s state health insurance exchange, or other private insurance. Overall, 61% (n=471) of our sample completed at least 3 total FIT tests or colonoscopy over the 6-year study period. There were significant differences in repeat FIT rates across the eight primary care clinics, ranging from 34% to 72%; the highest volume clinic had the highest repeat FIT rate. Significantly higher rates of repeat FIT were also observed among patients with frequent encounters and who were Latino vs. non-Latino (65% vs. 42%), Spanish-speaking vs. not (68% vs. 40%), uninsured or self-pay vs. publicly or privately insured (70% vs. 49%); all p&amp;lt;0.05.Conclusions. Findings suggest significant patient and clinic variation in completion of repeat FIT testing among active patients engaged in care. These results support the need for interventions to improve recurrent, guideline-concordant FIT screening in low-resource clinical settings that deliver essential cancer screenings to medically underserved populations. Citation Format: Narissa J. Nonzee, Beth A. Glenn, Debra Rosen, Alison K. Herrmann, Folasade P. May, L. Cindy Chang, Catherine Crespi, Alicia Lwin, Christine Park, Analissa Avila, Roshan Bastani. A longitudinal evaluation of repeat colorectal cancer screening in a Federally Qualified Health Center (FQHC) [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A112.

Abstract A104: Partnering with primary care to implement evidence based interventions (EBI) to address overdue colorectal cancer (CRC) screening in Connecticut (CT)

Abstract PURPOSE: Partnering with the largest Federally Qualified Health Center (FQHC) in New Haven, CT, the goal is to implement and test 4 evidence-based interventions (EBI) to increase CRC screening, while evaluating real-world implementation. Here, we report on the six-month (approximate) follow up of a cohort of 3,127 patients overdue for CRC screening who received 1 or more EBIs in October 2021. BACKGROUND: Sociocultural and medical concerns are barriers to colonoscopy uptake contributing to disparities in CRC screening. An additional barrier is system level capacity. COVID-19 associated delays exacerbated the existing backlog of individuals overdue for CRC screening, underscoring the need to expand Fecal Immunochemical Testing (FIT) capacity. This was particularly evident in the safety-net primary care setting that serves lower socio-economic status individuals living in urban New Haven, CT. METHODS: We are testing the unique and additive value of multiple evidence-based interventions (EBIs) for increasing CRC screening. The EBIs include the use of medical reminders, addressing the structural barriers (social determinants of health [SDOH]), and providing assistance from community health workers (CHW). We randomized 3,127 patients overdue for CRC screening to one of 4 arms of the study. All individuals received a reminder from their providers that they were due/overdue for CRC screening with instructions to contact the FQHC. Arm 2 also included information on SDOH barriers, Arm 3 included this same information with offer of navigation from CHW/navigator; and Arm 4 included the offer of CHW educational video and support if needed. Six-month (approximate) outcomes include: 1) Engagement with FQHC resulting in ordered test; 2) completed test. Results by intervention will be assessed at 12 months. RESULTS: Of the 3,127 randomized patients, ages 50-75, 77% were Hispanic (33%) or Black (44%). At 6+ months, a preliminary look at EMR data show that a minimum of 1,275 (40.8%) patients “engaged” with providers resulting in an ordered FIT Kit (n= 1174) or COMPLETED screening colonoscopy that was not associated with a positive FIT result (n = 102). 217 (18.5%) individuals completed the FIT testing with 13 requiring confirmatory colonoscopy (31% completed at this time). Thus, a minimum of 319 (10%) of 3,127 individuals in the cohort completed CRC screening at approximately 6 months post intervention. DISCUSSION: Despite investments in community engagement, stakeholder input, and FIT kit capacity building, the pandemic presented unforeseen challenges. Flexibility and steadfast commitment from FQHC providers and staff were critical to successful implementation during multiple waves of COVID-19, resulting in CRC screening ordered for 41% of cohort within 6 months of intervention. SUMMARY: At 6 months follow up of 3,127 individual who were overdue for CRC screening, one or more of 4 EBIs, in addition to system level efforts to address CRC screening, resulted CRC screening tests ordered for 41% of cohort with at least 10% completed screening. Citation Format: Beth A. Jones, Sakinah C. Suttiratana, Sarah A. DeGiovanni, Steven J. Parra, Levita Robinson, Michael Couturie, Louie Mar Gangcuangco, Denise Stevens. Partnering with primary care to implement evidence based interventions (EBI) to address overdue colorectal cancer (CRC) screening in Connecticut (CT) [abstract]. In: Proceedings of the 15th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2022 Sep 16-19; Philadelphia, PA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2022;31(1 Suppl):Abstract nr A104.

Neighborhood socioeconomic status and the effectiveness of colorectal cancer screening outreach with mailed fecal immunochemical tests within a safety net healthcare system in San Francisco, CA: A subgroup analysis of a randomized controlled trial

Neighborhood context shapes opportunities and barriers for residents to access healthcare and cancer screening. Neighborhood socioeconomic status (nSES) is associated with disparities in colorectal cancer (CRC) screening, but the extent to which the effectiveness of specific screening interventions vary by nSES has not been studied. The original trial conducted in San Francisco, CA from 2016 to 2017 randomly assigned patients eligible for CRC screening either to a multicomponent intervention including advanced notification, mailed fecal immunochemical test (FIT) kits and reminders or to a control group receiving usual care. For the nSES analysis addresses for 9699 patients were geocoded and stratified by city-wide nSES quintile (Q1 lowest, Q5 highest) using an established index at the census tract level. Compared to usual care, the outreach intervention improved FIT test completion at one year (58.7% vs 38.4%; OR 2.32 [2.14, 2.52]) but its effectiveness did not vary substantially by nSES quintile (adjusted OR Q1 2.64 [2.30, 3.04]; Q2 2.43 [2.04, 2.90]; Q3 2.31 [1.84, 2.89]; Q4 2.47 [1.86, 3.28]; Q5 2.64 [1.83, 3.81]; Wald test for interaction p = 0.87). The implementation of mailed FIT outreach has the potential to increase CRC screening completion without leading to disparities in screening related to nSES (ClinicalTrials.gov NCT02613260).

Evaluation of the stability of fecal immunochemical test specimens

Fecal immunochemical tests (FIT) are used to screen for colorectal cancer by detecting blood present in stool. Patients collect FIT specimens at home in a sampling kit and return them to the lab for testing. At our institution, patients are instructed to return their specimens to the laboratory within seven days from collection, which is shorter than the manufacturer stated room temperature (RT) stability of 15 days. The objective of this study was to assess and verify the stability of FIT specimens at RT and to determine if refrigerated storage improves stability. A series of experiments were performed with the OC-Sensor DIANA iFOB Test system between 2017 and 2019, using a positive clinical cut-off of 75 ng/mL (15 µg/g) hemoglobin (Hb). Specimens were collected and categorized based on their initially measured Hb concentration and had repeated measurements for up to 21 days following collection. FIT specimens were stored either at RT or refrigerated. Our results show that FIT specimens have reduced concentrations of Hb compared to baseline when stored at RT; refrigeration improved FIT specimen stability but did not completely prevent the reduction in Hb concentration. Additionally, specimens marginally above the cut-off (initial concentrations between 75 and 100 ng/mL (15–20 µg/g)) that were stored at RT showed 100% positivity on the day of collection (n=33), 63% on Day 3 (n=19), 46% on Days 4/5 (n=26), and 38% on Days 6/7 (n=26). Finally, specimens with Hb values near the clinical cut-off appear to be particularly susceptible to false negatives as a result of the reduction in Hb over time. Therefore, laboratories should verify the specifics of their FIT tests before offering it to patients to reduce false negatives.

A Health Equity Study on Access by Ethnicity to Fecal Immunochemical Testing for Colorectal Cancer Screening at a Veteran Affairs Medical Center

Abstract Introduction/Objective It has been documented in the literature that significant ethnic and racial disparities in access to healthcare exist. Additionally, it has also been shown that these disparities can be corrected. Integrated health care systems such as the Veterans’ Administration health care system have previously been demonstrated to lead to more equitable care delivery and improved outcomes with lower racial and ethnic differences in access to care. Standard of care guidelines issued by the U.S. Preventive Services Task Force (USPSTF) exist recommending screening for colorectal cancer in adults, of which one of the screening methods involves the convenient fecal immunochemical test (FIT). FIT is a noninvasive simple screening test compared to alternatives such as colonoscopy. Given FIT’s benefits, the authors explored the accessibility by ethnicity for this important test at a Veteran Affairs Medical Center (VAMC). Methods/Case Report A search of all FIT testing performed at a regional VAMC from 10/1/2018 to 6/4/2022 was performed to determine the patient demographics including age, gender, and ethnicity. The ethnic distribution of all tested patients was compared to the local census population demographics of the county (Philadelphia) in which the VAMC is located (updated July 1, 2021). Results (if a Case Study enter NA) There were a total of 10,110 FIT tests conducted during the study period. From these 10,110 FIT tests, the ethnic composition of the test population is as follows: 5,164 or 51% (5,164/10,110) were African American, 4,389 or 43% (4,389/10,110) were Caucasian American, 65 or 0.6% (65/10,110) were Asian American, 48 or 0.5% were American Indian or Alaska Native American, 111 or 1% (111/10,110) were Native Hawaiian or other Pacific Islander Americans, and 333 or 3.2% (333/10,110) were unknown or declined to state in the medical record. Per the local county census, 44.8% of the local population was Caucasian American and 43.6% were African American. Conclusion The VAMC, being an integrated health care system, provides equitable access to FIT to screen for colorectal cancer.

Addressing Barriers to Colorectal Cancer Screening by Implementing a Colorectal Cancer Screening Program on a Mobile Health Unit

INTRODUCTION: Several barriers to healthcare access contribute to disparity in colorectal cancer screening. We developed a program to address structural and financial barriers to colorectal cancer screening in our community using an established mobile health unit. METHODS: This mobile health team aims to improve health and prevent chronic disease by providing wellness education and taking physiological measurements such as glucose and blood pressure. In partnership with this unit, we began providing fecal immunochemical test (FIT) tests to English- and Spanish-speaking patients aged 45 years and older during their visits to the mobile unit for other health examinations. Participants complete the FIT at home and return it via postal mail. A patient navigator follows up with participants. If the FIT is positive, the participant undergoes a colonoscopy. If the participant is uninsured, cost of colonoscopy and/or cancer care are covered by our institution. Participants complete surveys at baseline, test completion, and upon receiving their results. RESULTS: We have enrolled 34 participants, 65% women, median age: 55 years (interquartile range = 12). The majority (90%) of patients did not have health insurance, and 76% were Spanish-speaking. Most (88%) knew they were due for colorectal cancer screening, but 85% had never been screened for various reasons (Table). To date, 71% of participants have completed FIT testing, and 100% of completion survey respondents plan to repeat FIT testing next year. CONCLUSION: Our preliminary results demonstrate the feasibility of addressing structural and financial barriers to colorectal cancer screening by initiating FIT testing programs on existing mobile community health units. Table. - Enrollee-Reported Primary Past Barriers to Colorectal Cancer Screening Barrier Percentage I’ve never had the opportunity 26% I don’t have insurance 19% I didn’t think it was necessary 14% Testing is too expensive 11% I don’t know 11% Other 19%

S2246 FIT or Unfit: Advanced Colon Cancer Screening

Introduction: Colorectal cancer (CRC) is the third leading cause of cancer related mortality worldwide. The U.S. Preventative Services Task Force guidelines recommend screening for average risk patients at age 45, and modalities include stool-based or direct visualization tests. We report a presentation of Stage IV colorectal adenocarcinoma in the setting of 3 annual negative fecal immunochemical testing (FIT) tests. Case Description/Methods: A 67-year-old woman presented with shortness of breath, unintentional weight loss, and abdominal pain. She denied hematochezia or melena. Physical exam was notable for pallor and right upper quadrant pain. Initial laboratory data showed normocytic anemia with a hemoglobin 10.1 g/dL, alkaline phosphatase 610 U/L, aspartate aminotransaminase 116 U/L, alanine aminotransaminase 67 U/L. Computed tomography of the chest, abdomen, and pelvis revealed a normal colon and extensive metastatic disease in the liver and lungs with bilateral subsegmental pulmonary emboli. Chart review was notable for negative FIT tests in 2017, 2018, and 2020, performed within a year of this presentation. Further workup was significant for elevated carcinogenic embryonic antigen 1470 ng/mL, and normal alpha-fetoprotein and cancer antigen 19-9 levels. Colonoscopy revealed an infiltrating, ulcerated, semi-circumferential mass at the ileo-cecal valve and ascending colon (Figure). Pathology demonstrated moderately differentiated invasive colonic adenocarcinoma with malignant glands infiltrating a desmoplastic stroma. Immunohistochemistry did not show any microsatellite instability changes. Discussion: One study showed FIT testing was 73.8% sensitive for detecting Stage I-III CRC, however, sensitivities dropped with advanced precancerous lesions and sessile serrated polyps to 23.8% and 5.1% respectively. Another retrospective cohort looking at 6 consecutive rounds of FIT testing demonstrated lower accuracy of detecting proximal colon cancers compared to distal cancers (0.45 vs 0.73; P< 0.001). Lower cut off values of qualitative FIT correlated with better sensitivities, however, specificity declined. Although FIT testing is able to detect the majority of colorectal cancers, it has decreased accuracy and sensitivity in advanced precancerous lesions, sessile serrated polyps, and proximal (right) colon lesions. Colonoscopy is considered gold standard and further guidelines should recommend a standardized cut off value to help improve screening efficacy.Figure 1.: Large fungating mass in the ascending colon and ileo-cecal valve.

S295 Preliminary Observations of FIT Testing for Colorectal Cancer (CRC) Prevention in Two Public Hospitals in New York City

Introduction: Expanding colorectal cancer screening (CRC) on a population level is essential in decreasing CRC mortality. Fecal immunochemical test (FIT) has an important role in improving screening rates. Currently, CRC guidelines recommend annual fecal immunochemical test (FIT) with follow up colonoscopy for all positive tests. We reviewed our experience with FIT testing for CRC screening at our institutions between July 2019 and December 2021. Methods: Eligible primary care clinic patients were given FIT kits with information on how to perform and submit the samples either during face-to-face visits or by mail. Eligible patients were identified as those aged 50-75 due for CRC screening, defined as those without a colonoscopy in the prior 10 years or FIT kit in the prior one year. Among patients who received FIT kits by mail, no standard education was provided about CRC, its screening, or the role of colonoscopy in prevention. A de-identified database was constructed containing demographic variables, process measures, colonoscopy quality measures and outcome measures in FIT+ patients. Results: One hundred seventy-six patients had positive FIT with a positivity rate of 7.2%. Mean age was 60+/-12 years and 52% were female. Follow up colonoscopies were ordered in 73% and performed in 52% of those ordered, representing only 38% of all positive FIT requiring a follow up colonoscopy. Mean and median intervals between +FIT and colonoscopy was 4 months. Of colonoscopies not performed, the patient refused in 54% while system issues were responsible in 21%. Quality metrics, including cecal intubation rates, withdrawal times, and adenoma detection rates (ADR) all met or exceeded benchmarks. The ADR was 58%, almost twice the benchmark, and the detection rate for advanced adenomas was 21%. Eight patients had cancers (11.9%) of which 6 had signs or symptoms and 4 were advanced. There were no interval cancers detected and no complications occurred. Conclusion: Among primary care clinic patients with positive FITs, we found that a low percentage completed their follow up colonoscopies. Among those who did complete colonoscopy, there were high detection rates for both adenomas and advanced adenomas. This highlights the importance of colonoscopy and demonstrates that enhanced pre-FIT educational efforts may be needed to increase adherence to colonoscopy follow up in patients with positive FIT results.

S337 Colonoscopy Quality Metrics After a Multi-Target Stool DNA or Fecal Immunochemical Test: A Systematic Review and Meta-Analysis

Introduction: Colorectal cancer (CRC) accounts for approximately 50,000 deaths or 14 deaths per 100,000 people yearly in the United States. Multi-target stool DNA (mt-sDNA) and fecal immunochemical test (FIT) are validated CRC screening strategies in average-risk asymptomatic individuals. This study aims to evaluate the colonoscopy quality metrics following a positive mt-sDNA test, FIT. Methods: We performed a comprehensive search in the databases of PubMed/MEDLINE, Embase, and the Cochrane Central Register of Controlled Trials from inception through May 2022. Meta-analysis was performed by standard methodology using the random-effects model and heterogeneity was assessed using the I2% statistics. Outcomes of interest were adenoma detection rate (ADR), colorectal cancer detection rate (CRCDR), withdrawal time (WT), and cecal intubation rate (CIR). Results: 27 high-quality studies (97825 patients) were included in the analysis. 94161 had a positive FIT test in 23 studies and 3664 had positive mt-sDNA in 4 studies. The pooled WT after positive mt-sDNA was 16.1 minutes (95% CI 9.4-22.8, I2=99%), whereas after positive FIT was 11.6 minutes (10.9-12.3, 99%). The corresponding WT in the negative tests was 13.2 minutes (12.7-13.7) for mt-sDNA and 10.2 minutes (9.3-11.2) for FIT. The pooled ADR was 73% (69.9-75.8) and CRCDR was 1.9% (0.9-4.2) in mt-sDNA positive. The pooled ADR was 54.2% (49.8-58.4) and pooled CRCDR was 4% (3.2-4.9) in FIT positive. Pooled CIR were excellent: 99% (98.6-99.3) in mt-sDNA positive, and 96.8% (95.8-97.6) in FIT positive. Pooled rates are summarized in Table. Conclusion: Our meta-analysis demonstrated that positive mt-sDNA or FIT patients had a higher WT and CIR when compared to negative or unknown tests. ADR and CRCDR were high, however, it is not known if it is secondary to positive stool test or to longer WT. Future studies are needed to validate our findings and determine the cost-effectiveness of these screening tests. Table 1. - Colonoscopy quality metrics including withdrawal time, cecal intubation rate, adenoma detection rate and colorectal cancer detection rate after positive and negative multi-target stool DNA and fecal immunochemical test testing Outcomes Multi-target stool DNA (mt-sDNA) Fecal Immunochemical Test (FIT) Withdrawal time (WT), mean (95%CI) Positive: 16.1 (9.4-22.8) (SE: 3.4);4 studiesNegative: 13.2 (12.7-13.7) (SE: 0.2)1 study Positive: 11.6 (10.9-12.3) (SE: 0.3);22 studiesNegative: 10.2 (9.3-11.2) (SE: 0.5)6 studies Cecal intubation Rate (CIR), pooled rate (95%CI) Positive: 99% (98.6-99.3)2 studies Positive: 96.8% (95.8-97.6, 94%)12 studies Adenoma Detection Rate (ADR), pooled rate (95%CI) Positive: 73% (69.9-75.8)1 studyNegative: NR Positive: 54.2% (49.8-58.4, 97%)20 studiesNegative: 35.1% (30.5-39.9, 95%)6 studies Colorectal Cancer Detection Rate (CRCDR), pooled rate (95%CI) Positive: 1.9% (0.9-4.2, 81%)3 studiesNegative: 7.9% (2.6-21.8)1 study Positive: 4% (3.2-4.9, 88%)17 studiesNegative: 0.5% (0.2-1.6, 85%)5 studies Abbreviations: NR: not reported, SE: standard error, CI: confidence interval.