Average-risk Patients Research Articles

Annual incidence of colorectal cancer among patients with average risk in the United States between 2017 and 2023.

83 Background: Colorectal cancer (CRC) is the second most common cause of cancer-related mortality and third most common cancer in the United States. In 2021, 141,902 new cases of CRC were reported. With recent increases in early onset of CRC incidence, a shift in patterns amongst various demographics has been observed. Together with an estimated 60% increase in burden of CRC globally, it is important to continuously assess the nationwide incidence rates and monitor the changing patterns. In this study, we examined the annual incidence rates of CRC in average risk adults using a large national claims database and report patterns of incidence based on various demographic characteristics. Methods: CRC diagnoses were retrospectively identified from a large national claims database, which covers over 165 million lives and is representative of the U.S. population, for each calendar year during the study period from 2017 to 2023. Individuals aged 45 to 75 years, with an average risk of CRC before each index calendar year were included in the study. Individuals were required to be continuously enrolled in the same health plan for at least 1 year prior to and 1 year following the index year. Annual CRC incidence rates per 100,000 people were calculated for each year from 2017 to 2023 within various subgroups based on baseline demographics. Results: Overall, annual CRC incidences remained consistent during the study period with 186.86 (95% CI, 184.87-188.86) cases in 2017 and 183.40 (95% CI, 181.32-185.5) cases in 2023 per 100,000. Among younger adults aged 45-49 years, the annual CRC incidence increased by 66% from 2017 (92.04 cases/100,000) to 2023 (153.12 cases/100,000). Conversely, annual CRC incidence decreased by 25% between 2017 (328.52 cases/100,000) and 2023 (244.93/100,000) in older adults aged 65-75 years. Over the study period, CRC incidence in men was higher than women with an overall rate ratio (RR) of 1.206 (95% CI, 1.122-1.297). African American adults had higher CRC incidence than White Americans with an overall rate ratio (RR) of 1.216 (95% CI, 1.152-1.283). Conclusions: Based on this large study of national claims data, CRC incidence rates remained relatively stable in the total population among average-risk patients from 2017 to 2023. The continuing increase in recommended CRC screening utilization showed a decreased incidence rate in the older population, while observing increased incidences among younger patients.

Clinical outcomes and molecular characteristics of patients with locoregional ampullary carcinoma.

732 Background: Ampullary carcinoma (AC) is a rare malignancy arising from the ampulla of Vater which has a more favorable prognosis compared to other pancreatic malignancies. Current guidelines favor surgical resection followed by adjuvant therapy for average risk patients (pts), however the type of regimen as well as other perioperative treatment modalities are still being explored. The objective of this retrospective study aims to provide insight into the management of locoregional disease. Methods: Pathology records from Mayo Clinic (AZ, FL, MN) denoting AC between 2010 to 2024 were searched using Mayo Data Explorer and selected for retrospective review. Pt demographics, treatment courses, and next generation sequencing (NGS) data were collected. Statistical analysis was conducted using SAS version 9.04. Results: A total of 137 pts (62% male, n = 85) were identified with median age 66 years old. Histologic subtypes were 54% pancreatobiliary (44/81), 40% intestinal (32/81), 6% mixed (5/81), with 56 pts unknown. Stages at diagnosis were 81% resectable (111/137), 11% locally advanced (15/137), and 8% metastatic (11/137). Nearly all (93%, n = 103/111) pts with localized disease had resection with a 97% R0 resection rate (100/103). Majority (68%, n = 75/111) of resectable pts had perioperative chemotherapy with 5-FU or gemcitabine-based regimens (24%, n = 18/75 neoadjuvant vs. 76%, n = 57/75 adjuvant). Perioperative chemoradiation was given in 17% (19/111) of pts. At median follow up of 30.5 months, recurrence rates were 40% (41/103), primarily to the liver (18/41). Median recurrence free survival (RFS) was 29.3 months (95% CI 24.7 – NE). Median overall survival (OS) has not been reached. The 5-year RFS and OS rates were 0.37 (95% CI 0.25 - 0.55) and 0.69 (95% CI 0.58 - 0.82), respectively. Univariate analysis showed no difference in OS with the addition of neoadjuvant or adjuvant chemotherapy or chemoradiation. Somatic NGS testing showed pathogenic mutations in 90% of pts (63/70): 57% KRAS (36/63; 44% G12D, 19% G12V, 8% G12C, 8% G12D, 19% others); 13% homologous recombination (HR) (8/63); 6% ERRB2 /Her2 amplification (4/63), and 5% mismatch repair (MMR) (3/63). Conclusions: AC has a favorable prognosis in resectable pts. However, high recurrence rates indicate the need for better systemic therapies and improved selection of pts who would benefit from these treatments. Future research should focus on refining perioperative strategies to enhance outcomes and reduce recurrence.

The Use of Blood-Based Biomarkers in the Prediction of Colorectal Neoplasia at the Time of Primary Screening Colonoscopy Among Average-Risk Patients: A Systematic Literature Review.

Risk prediction models (RPMs) for colorectal cancer (CRC) could facilitate risk-based screening. Models incorporating biomarkers may improve the utility of current RPMs. We performed a systematic review of studies reporting RPMs for CRC that evaluated the impact of blood-based biomarkers on clinical outcome prediction at the time of screening colonoscopy in average-risk populations. We conducted a search of MEDLINE, Web of Science, and PubMed databases from inception through April 2024. Studies that developed or validated a model to predict risk of CRC or its precursors were included. Studies were limited to those including patients undergoing average-risk CRC screening. Sixteen studies published between 2015 and 2024 were included. Outcomes included CRC (16 studies) and high-risk adenomas (1 study). Using a complete blood count was the most common biomarker and was able to achieve an AUC of 0.82 and a specificity of 0.88. Other blood-based biomarkers included were various serum proteins/metabolites/enzymes, plasma metabolites, insulin-related factors, and anemia markers. The highest-performing model, with an AUC of 0.99, involved the use of a plasma metabolite panel. The evidence base of RPMs for CRC screening is expanding and incorporating biomarkers, which remain a prominent aspect of model discovery. Most RPMs included a lack of internal/external validation or discussion as to how the model could be implemented clinically. As biomarkers improve the discriminatory potential of RPMs, more research is needed for the evaluation and implementation of RPMs within existing CRC screening frameworks.

Abstract A027: Systematic review of real-world adherence to blood-based laboratory tests for average-risk disease screening: potential implications for emerging colorectal cancer screening modalities

Abstract Introduction: Blood-based tests represent a compelling option for early detection and management of cancers and other chronic diseases. While blood-based tests may offer potential to increase patient engagement, the assumption of greater adherence in clinical practice requires further evaluation. This systematic review aimed to evaluate the real-world adherence to established blood-based tests for commonly recommended screening indications, to better inform expectations for proposed application to average-risk colorectal cancer (CRC) screening. Methods: A systematic search of PubMed, Embase, and citations was performed to identify literature published from 2010 to 2023. Studies examined adherence to routine blood-based laboratory tests with a Grade A or B recommendation per the United States Preventive Services Task Force (USPSTF) for diabetes, dyslipidemia, human immunodeficiency virus (HIV), and hepatitis C virus (HCV) in an average-risk patient population were included. In addition, prostate-specific antigen (PSA) testing adherence for prostate cancer screening (Grade-C USPSTF recommendation), the only commonly accessible blood-based single-cancer screening test for average-risk adults, was also included. Studies without venipuncture-derived blood were excluded. Results: Of 53,067 articles screened, 69 were included in the analysis. Overall, adherence rates of blood-based tests were highly variable, with median values (interquartile range, IQR) of 66.3% (11.8%), 67.8% (18.0%), 34% (28.7%), and 36.8% (30%) for diabetes, dyslipidemia, HCV, and HIV, respectively. PSA testing adherence was 37.2% (18.4%). Beyond disease type, adherence varied by study design, data source, patient characteristics, clinical setting, and study country. Information and selection bias were the most common risks of bias. Conclusions: Based on data from this comprehensive systematic review, real-world adherence to currently recommended, blood-based screening strategies is suboptimal. Future research is needed to identify the extent to which these data are generalizable to blood-based CRC screening, and to determine if/how this candidate strategy would impact clinical, economic, and health equity outcomes. Citation Format: Quang A. Le, Takako Kiener, Heather A. Johnson, Rukaiyya S. Khan, Joyce Kong, Kevin H. Li, Gina Thompson, A. Burak Ozbay, Mallik Greene, Paul J. Limburg, A. Mark Fendrick, John B. Kisiel, Derek W. Ebner. Systematic review of real-world adherence to blood-based laboratory tests for average-risk disease screening: potential implications for emerging colorectal cancer screening modalities [abstract]. In: Proceedings of the AACR Special Conference: Liquid Biopsy: From Discovery to Clinical Implementation; 2024 Nov 13-16; San Diego, CA. Philadelphia (PA): AACR; Clin Cancer Res 2024;30(21_Suppl):Abstract nr A027.

The Utility of Multitarget Stool DNA Testing for Colorectal Cancer Screening After a Normal Colonoscopy.

Multitarget stool DNA (MT-sDNA) tests (here, Cologuard®) are currently used in average-risk patients as a primary method of screening for colorectal cancer. However, MT-sDNA testing has also been used in patients who previously underwent colonoscopy who wish to avoid repeat colonoscopy. Here, in a large primary care practice setting, our aim was to evaluate the diagnostic performance of MT-sDNA testing in patients with a previously normal colonoscopy. This retrospective cohort study included 5827 patients from 35 different primary locations in South Carolina. Patients aged 45 and above with a previously documented normal, high-quality colonoscopy prior to the MT-sDNA test date were included. High-risk patients and those with a previous negative MT-sDNA result were excluded. Of 5827 ordered MT-sDNA tests, 248 patients had a prior normal colonoscopy. The average time from initial colonoscopy to MT-sDNA testing was 7.3years. Of the 63 patients who had a positive MT-sDNA test, 41 patients (65%) completed follow-up colonoscopy and 40 patients had complete colonoscopy data. Of these 40 patients, 12 patients (30%) had advanced adenomas and none had colorectal cancer. Compared to patients without a previous colonoscopy, patients with prior colonoscopies had fewer adenomas of all types (1.6 vs 2.4) and fewer advanced adenomas (1.4 vs 2.0). Patients with a previously negative colonoscopy and subsequent positive MT-sDNA test were found to have a high rate of advanced adenomas on follow-up colonoscopy (30%). Thus, in patients with a previously negative colonoscopy, MT-sDNA testing may be a reasonable alternative screening option.

B-330 Reducing Inappropriate Fecal Immunochemical Test

Abstract Background Colorectal cancer is the third most common cancer worldwide. The risk of colorectal cancer increases with age and predominantly affects individuals over the age of 50. Regular screening is crucial for early detection and prevention of colorectal cancer. Pre-cancerous polyps and colorectal cancers can bleed into the gastrointestinal tract. While the presence of blood in the stool cannot always be seen visually, it can be detected by the Fecal Immunochemical Test (FIT), currently the most sensitive method for directly measuring hemoglobin in this specimen type. In our province, FIT is recommended for testing average-risk asymptomatic patients aged 50 to 74 every 1-2 years. Patients aged 40 to 49 or 75 to 84 can be tested if they meet specific criteria. Like many other tests in the lab, FIT can be used inappropriately. The focus of this study was to examine the utilization of FIT in our institution. Methods Data were collected from our institution's laboratory information system for the FIT performed on-site from July to December 2023. Results We performed 91,545 FIT tests during the 6-month period with an overall positive rate of 6.8%. Of the total tests performed, 87.9% were for patients aged 50-74 years, 10.6% for patients aged 40-49 or 75-84 years, and 1.2% for patients outside the approved age range. Each year, we performed over 2,000 FIT tests for patients outside the accepted screening age, with an estimated cost of over 30,000 CAD. Conclusions Our results showed a significant number of FITs were ordered inappropriately by healthcare providers. Considering the relatively high cost of FIT kits, labor, reagents, etc., the overall cost per reportable is significant. Thus, we have started engaging healthcare providers involved in FIT testing to strategize approaches to improve utilization.

Age Matters: Adenoma Detection Rates in Average-risk Screening Patients Aged 45 to 49 Compared With Those Aged 50 to 54.

This study aims to address gaps in medical knowledge by determining whether adenoma detection rate (ADR) in average-risk screening patients aged 45 to 49 is equivalent to screening patients aged 50 to 54. Current guidelines recommend initiating colon cancer screening at age 45, yet our understanding of the effects of ADR in average-risk individuals among 45- to 49-year-olds is still limited. A retrospective analysis was conducted on records of average-risk screening colonoscopies performed on patients aged 45 to 54 from January 2018 to August 2022. Exclusions were prior diagnoses of colorectal cancer or adenomatous polyps, inflammatory bowel disease, personal or family history of genetic cancer syndromes, incomplete colonoscopy, and inadequate bowel preparation. The primary outcome was ADR in the age 45 to 49 group compared with the age 50 to 54 group. Of the 3199 average-risk screening colonoscopies performed, 879 and 2116 patients were included in the age 45 to 49 and 50 to 54 groups, respectively. Both groups were predominantly female, White ethnicity, never smokers, and obese. ADR was found to be 27% in the age 45 to 49 group compared with 34% in the age 50 to 54 group (odds ratio 0.70, 90% CI: 0.60-0.83, P -value for equivalence=0.81 w/ margin 0.77 to 1.30). The study did not demonstrate equivalent ADR between the 2 age groups, with ADR being substantially lower in the age 45 to 49 group (27% vs. 34%). Despite this, the ADR in the 45 to 49 age range surpasses the established benchmark of 25%, supporting the decision to lower the screening age to 45 years. Ongoing national monitoring is essential to comprehensively evaluate the impact of these updated guidelines.

Abstract A130: Examining breast cancer screening completion: Comparing patient self-report and electronic health record data at a Federally Qualified Health Center during the SARS-CoV-2 pandemic

Abstract Intro: There is evidence to suggest that preventive services, such as breast cancer screening, were impacted during the SARS-CoV-2 pandemic with interruption in screening mammogram services during March-July 2020. Federally Qualified Health Centers (FQHCs) are a critical health system to help better understand pandemic sequelae among diverse patient populations so teams can better prepare for a future pandemic. US Preventive Services Task Force (USPSTF) recommends average-risk patients aged 50-74 screen for breast cancer biyearly. Based on USPSTF recommendations in 2021, 76% of non-Hispanic White women and 74 % of Latina women were up-to-date on mammography screening. Our study, RESTORE, focuses on understanding patient barriers and facilitators to completing breast cancer screening at one large urban FQHC during the pandemic. Here, we compare FQHC patient self-reported completion of breast cancer screening to documented breast cancer screening found in the electric health record (EHR). Methods: Patients (n=20) were interviewed between July 2023 and February 2024 about their healthcare utilization, breast cancer screening (including medical site), and health literacy throughout the COVID period (2018-2022). When a screening date was documented in the EHR, interviewers mentioned the screening date to participants during the interview. Interviews were audio recorded and transcribed. A preliminary review of these interviews was conducted to collect self-reported breast cancer screening date and compare it to the date in the EHR. Results: Interviewees’ average age was 65.1 years; 70 % were Spanish-speaking; 60% were Latino, and 95% were female. Of the Spanish-speakers, 8 out of 14 patients self-reported completing a mammogram between 2018-2022, with 2 of 8 reporting having completed it with an onsite vendor. Only 3 of these 8 mammograms were captured in the EHR. Of these three, 2 patients were prompted with the EHR date during the interview: one patient agreed with the date while the other rejected the date. Among the English-speaking patients, 4 out of 6 patients self-reported completing a mammogram between years 2018-2022, all of these 4 self-reported dates were captured in the EHR. Of these 4 patients, all were prompted with the EHR date, 3 agreed to the date and one rejected the date, with 3 of 4 reporting having completed it with an onsite vendor.Conclusion: Throughout COVID, FQHC patients sought mammogram screening; however, gaps in data systems limited completeness of the health system’s mammogram EHR data. Time delays between patient experience and interview dates, complicated our understanding of patients’ COVID experiences. The inconsistency between self-reported dates and EHR dates also creates challenges educating and convincing patients to stay up-to-date on screenings based on recommended intervals. Missing EHR data could have also impacted staff not accurately following-up for mammograms or referrals. Additional work is needed to understand the opportunities to better integrate FQHC EHR with mammogram vendor data systems. Citation Format: Anne Escaron, Crystal Gomez, Jennifer Schneider, Jennifer Rivelli, Fabian Hidalgo, Gloria Coronado. Examining breast cancer screening completion: Comparing patient self-report and electronic health record data at a Federally Qualified Health Center during the SARS-CoV-2 pandemic [abstract]. In: Proceedings of the 17th AACR Conference on the Science of Cancer Health Disparities in Racial/Ethnic Minorities and the Medically Underserved; 2024 Sep 21-24; Los Angeles, CA. Philadelphia (PA): AACR; Cancer Epidemiol Biomarkers Prev 2024;33(9 Suppl):Abstract nr A130.

The Impact of Computer-aided Detection Technology in Adenoma Detection Rate Among Experienced Endoscopists in the Community Setting.

Adenoma detection rate (ADR) is a key quality metric in screening colonoscopies. An adenoma detection rate of greater than 30% reduces the incidence of colorectal carcinoma (CRC). Furthermore, studies have demonstrated an inverse relationship between ADR and the incidence of CRC. Computer aided detection (CAD) can improve ADR, but these studies have largely been in major medical centers. In this retrospective single center observational study, screening colonoscopies in average-risk patients were compared among 5 experienced endoscopists in the year before and the year after implementation of the CAD (GI Genius). Training for GI Genius was completed in December 2021 and the technology was implemented the beginning of January 2022. We evaluated the adenoma detection rate (ADR) for 1838 screening colonoscopies in 2021 (before CAD incorporation) and 2629 screening colonoscopies in 2022 (after CAD incorporation) to assess efficacy of AI-assisted colonoscopy. Our study demonstrates that the incorporation of CAD technology in a group of experienced endoscopists in a community setting significantly improved ADR. The ADR of the entire group increased significantly (p < 0.05) following the implementation of CAD technology. The improvement in ADR was attributed to an increased detection of small (<6 mm) polyps. The clinical significance of improved detection of small polyps is uncertain, and further investigation should be done on the economical benefit of incorporating an AI model in the community setting.

The Recurrence Rate of Colorectal Polyps among Patients with Average Risk of Colorectal Cancer.

CRC is going to be an important issue in Middle East countries. Also, the main parts of this cancer develop from benign adenomas. To understand the recurrence rate of colorectal polyps among average-risk subjects. In a prospective study, the average-risk patients with colorectal adenoma were enrolled in this study based on inclusion criteria. The patients were consulted annually by an expert gastroenterologist. A control colonoscopy was programmed after three years of follow-up. It was not an obligation to follow our program, and each patient could exit the study at any time. The patient who developed one of the exclusion criteria was also withdrawn from the study by the gastroenterologist of this study. 237 patients were enrolled in this study. Of them, 102 patients completed their 3-year follow-up. Among these participants, 62 (60.8%) were male and 40 (39.2%) were female, with a mean age of 57.05 ± 12.87 years. Additionally, 20 (19.6%) subjects had adenomatous polyps at the end of the study. Patients with recurrent colorectal polyps tend to be raised in large ones with a tubulovillous morphology. The polyps were more commonly located in the sigmoid colon, rectum. Furthermore, high-grade dysplasia was recorded in 5 patients. Tubulovillous polyp had higher chance of recurrence than patients with tubular polyp. We believe the colonoscopy screening needs to be set up in regions previously considered low-risk for CRC. Also, it may be valuable to control colonoscopy for less than three years in patients with dysplasia.

Strategic use of resources to enhance colorectal cancer screening for patients with diabetes (SURE: CRC4D) in federally qualified health centers: a protocol for hybrid type ii effectiveness-implementation trial

BackgroundPersons with diabetes have 27% elevated risk of developing colorectal cancer (CRC) and are disproportionately from priority health disparities populations. Federally qualified health centers (FQHCs) struggle to implement CRC screening programs for average risk patients. Strategies to effectively prioritize and optimize CRC screening for patients with diabetes in the primary care safety-net are needed.MethodsGuided by the Exploration, Preparation, Implementation and Sustainment Framework, we conducted a stakeholder-engaged process to identify multi-level change objectives for implementing optimized CRC screening for patients with diabetes in FQHCs. To identify change objectives, an implementation planning group of stakeholders from FQHCs, safety-net screening programs, and policy implementers were assembled and met over a 7-month period. Depth interviews (n = 18–20) with key implementation actors were conducted to identify and refine the materials, methods and strategies needed to support an implementation plan across different FQHC contexts. The planning group endorsed the following multi-component implementation strategies: identifying clinic champions, development/distribution of patient educational materials, developing and implementing quality monitoring systems, and convening clinical meetings. To support clinic champions during the initial implementation phase, two learning collaboratives and bi-weekly virtual facilitation will be provided. In single group, hybrid type 2 effectiveness-implementation trial, we will implement and evaluate these strategies in a in six safety net clinics (n = 30 patients with diabetes per site). The primary clinical outcomes are: (1) clinic-level colonoscopy uptake and (2) overall CRC screening rates for patients with diabetes assessed at baseline and 12-months post-implementation. Implementation outcomes include provider and staff fidelity to the implementation plan, patient acceptability, and feasibility will be assessed at baseline and 12-months post-implementation.DiscussionStudy findings are poised to inform development of evidence-based implementation strategies to be tested for scalability and sustainability in a future hybrid 2 effectiveness-implementation clinical trial. The research protocol can be adapted as a model to investigate the development of targeted cancer prevention strategies in additional chronically ill priority populations.Trial registrationThis study was registered in ClinicalTrials.gov (NCT05785780) on March 27, 2023 (last updated October 21, 2023).

820 “Antibiotics Because We’re Inserting a Mesh”: A Study to Evaluate Antibiotic Prophylaxis in Elective Hernia Repairs

Abstract Aim Inguinal hernias are one of the most common pathologies worldwide. Over 20 million inguinal hernia repairs are performed each year. The HerniaSurge Collaboration recently updated their international guidelines for groin hernia management. They concluded that antibiotic prophylaxis is not recommended in elective open inguinal mesh hernia repairs in average-risk patients in a low infection risk environment. In laparoscopic hernia repairs, antibiotics are never recommended. This study aimed to identify current practice for antibiotic prophylaxis use in elective inguinal hernia repairs within our district general hospital environment. Method A retrospective study was performed, evaluating all elective inguinal hernia repairs with mesh between 1st June 2022-31st December 2022. Both laparoscopic and open techniques were included in this study. Operative notes were reviewed to ascertain if patients had been given antibiotics intra-operatively. Results The study identified 84 patients who underwent an inguinal hernia repair with mesh across a 7 month- period. Of these, all were operated on in a low-risk environment. 94% (N=79) were given antibiotic prophylaxis intraoperatively. Conclusions Antibiotic prophylaxis is still being used for low-risk patients undergoing elective inguinal hernia surgery. This is not in keeping with current hernia guidelines which suggests that there is no significant benefit to antibiotic use. Excessive antibiotic use is associated with an increase in adverse events, an increased rate of antibiotic resistant organisms and increased healthcare costs.

MDB-67. MEDULLOBLASTOMA MOLECULAR SUBGROUPING AND OUTCOMES DATA OF A SINGLE CENTER FROM A LOW-MIDDLE-INCOME COUNTRY

Abstract BACKGROUND Medulloblastoma is the most common malignant childhood brain tumor. The molecular subgrouping of medulloblastoma is a major determinant of management in high-income countries. Subgrouping is still very limited in low- and middle-income countries, and its relevance to management has yet to be evaluated in this setting. We describe molecular findings and their implications in the outcome of a single tertiary care center. METHODS Children between 3 and 18 years diagnosed with medulloblastoma between April 2014 and December 2020 at Aga Khan University Hospital were included. Subgrouping was performed by nanostring through a collaboration with the Hospital for Sick Children, Toronto. RESULTS Thirty-five children were identified (85.17% male); the median age was 8. Nineteen patients were high-risk, including 9 with metastatic disease. In 28 children, there was a clear molecular subgroup: 4 WNT (11.4%), 7 Sonic Hedgehog (20%), 3 Group 3 (8.6%), and 14 Group 4 (40%) medulloblastomas. Molecular subgrouping was inconclusive for two patients (5.7%) and not done in 5 patients (14.3%). All patients underwent surgery; 91.4% received radiation therapy and chemotherapy. Of 35 children, overall Survival at 5 years was 100%, 57.1%, 66.7%, and 85.7% for WNT, Sonic Hedgehog, Group 3, and Group 4, respectively. WNT and Group 3 had 100% Progression-free survival, whereas Sonic Hedgehog and Group 4 had decreased progression-free survival of 42.9% and 85.7%, respectively. Average-risk patients had an overall survival of 93.8%, whereas high-risk patients exhibited a statistically significant lower overall survival of 63.2% (P=0.014). CONCLUSION Our cohort demonstrates excellent outcomes for WNT and Group 4, despite one WNT being metastatic and four Group 4 patients being high-risk. Modern risk stratification is an excellent predictor of survival, suggesting that treatment can be tailored according to subgrouping in the LMIC setting.

Are cancer screening recommendations from top US cancer centers concordant with the USPSTF guidelines?

10535 Background: The USPSTF is an independent volunteer organization of multi-disciplinary national experts in disease prevention that publishes evidence-based non-binding recommendations for screening diseases, including cancer. Herein we assessed the congruence of cancer screening recommendations between the USPSTF and the Top 10 US Cancer Centers (as per the U.S News and World Report). Methods: This cross-sectional study compared the published screening recommendations from the Top 10 US Cancer Centers for colorectal (CRC), lung (LC), cervical (CC), prostate (PC), and breast cancers (BC) in average risk patients, to those of the USPSTF. The variables of interest included: screening tests, recommendation direction (for/against), strength, frequency, age of start, age of end, and discussion about risks and benefits. Data extraction was done by 2 authors and discrepancies resolved by mutual consensus and discussion with a third author. Results: We demonstrate the differences between the screening recommendations from the Top 10 Cancer Centers relative to those from the USPSTF (Table). Conclusions: Our study found significant variability between the screening recommendations from the 2022-2023 USNWR top 10 cancer centers and the evidence-based USPSTF guidelines for BC, PC, CC, and CRC. The recommendations for LC were overall in line with those of the USPSTF. The discordance was almost always in the direction of the cancer centers recommending more screening beyond the USPSTF’s recommendations, and often without discussion of potential risks and harms. This inconsistency could create confusion to the public, and therefore, a consistent messaging across the cancer centers congruent with the USPSTF recommendations and including a nuanced discussion of benefits and risks may be in the best public health interest.[Table: see text]

Stakeholder Perspectives of the PATH (Plan for Appropriate Tailored Healthcare in Pregnancy) Targeted Visit Schedule Recommendation [ID 2683601

INTRODUCTION: Traditional prenatal care delivery guidelines recommend 12–14 in-person visits for all patients, although care can be safely delivered to average-risk patients with 8–9 targeted visits. These additional visits may result in oversurveillance and unnecessary interventions. The Plan for Appropriate Tailored Healthcare in Pregnancy (PATH), a consensus-based prenatal care recommendation developed by a multidisciplinary team of prenatal care experts, recommends tailoring care delivery to patients' needs by using targeted visit schedules for average-risk patients. A national listening tour was conducted to obtain stakeholder feedback for incorporating this care delivery model into practice. METHODS: We conducted nine, 120-minute virtual focus groups with more than 25 organizations including professional (8), patient advocacy (8), public health (5), and payer groups (4). Focus groups were transcribed and coded by recommendation, and analyzed with matrix coding across positive attitudes, negative attitudes, and implementation considerations. RESULTS: Focus groups included 110 participants. Positive attitudes included the belief that targeted visit schedules would improve visit attendance, care flexibility, and resource equity. Negative attitudes included concerns for inappropriate targeted visit schedule application, inadequate safety net systems for missed services, and reduced payer reimbursement. Providers were also concerned about decreased opportunities for relationship building and counseling in targeted visit schedules. Implementation considerations included the importance of shared decision-making, serial needs assessments, and clear risk stratification guidelines. Participants emphasized the need for multidisciplinary safety net processes to ensure timely, adequate care. CONCLUSION: Participants were receptive to incorporating targeted visit schedules for average-risk individuals into routine prenatal care. Greater infrastructure investment is needed to implement more flexible care models successfully.

Evaluating the Efficacy of 6-Month Follow-Up for BI-RADS 3 Lesions Identified by Screening Ultrasound: A Retrospective Study

Background: The Breast Imaging-Reporting and Data System (BI-RADS), developed to standardize mammographic findings, categorizes 'probably benign' lesions as BI-RADS 3, aiming to reduce unnecessary biopsies from false positives, with a cancer likelihood of less than 2%. In some countries, screening programs have been expanded to include ultrasound alongside mammography, particularly in populations with predominantly dense breast tissue, leading to an increased detection of BI-RADS 3 lesions through this additional modality. This study examines the effectiveness of 6-month follow-ups for these ultrasound-identified BI-RADS 3 lesions. The purpose is to evaluate cancer detection rates and diagnostic performance of ultrasound findings leading to decision for biopsy. Materials and Methods: We retrospectively analyzed 7,577 women who underwent mammography and ultrasound screening from January 2016 to December 2021. Of these, 2,907 were classified as BI-RADS 3 based on ultrasound findings. The study focused on 1,163 patients with normal mammography and assessed BI-RADS 3 from ultrasound findings, who completed a 24-month follow-up. Data analysis included assessing demographic data, breast cancer risk, imaging features, and pathological findings. Results: Among the 1,163 patients, the cancer detection of the entire cohort was 0.7%, with no cancers detected during the first six months. The cancer found at 6 months and 12-24 months were 0 and 0.17%, respectively (p&lt;0.001). The median time to be reassesed from BI-RADS 3 to BI-RADS 4 was 18.4 months. Upon the change of BI-RADS, spiculation and angular margins were the most predictive ultrasound features for malignancy (AUROC=0.75 and 0.69, respectively). Lesion size growth alone was found insufficient as a biopsy criterion. A 28% growth cutoff distinguished between benign and malignant lesions better than 20% cutoff (AUROC=0.68 vs 0.64, p=0.038). Conclusion: A 12-month follow-up interval may be more appropriate than the traditional 6-month interval for average-risk patients with BI-RADS 3 lesions detected by screening ultrasound. Combining suspicious imaging features with size increases enhances diagnostic accuracy, proposing a tailored follow-up approach based on individual risk profiles and imaging characteristics.

Renal transplant recipient and deceased-donor risk profiles at Wits Donald Gordon Medical Centre, Johannesburg, South Africa: A 9-year review.

Renal transplantation is the gold-standard therapy for end-stage renal disease. Decision-making around the acceptance of deceased-donor organs is complex and time sensitive. Risk scoring systems for both donors and recipients attempt to simplify the allocation of renal grafts to the most appropriate recipient. To investigate the role of these transplant risk scores in the South African (SA) setting. A total of 188 adult deceased-donor organ referrals over the 9-year period 1 January 2013 - 31 December 2021 were included. The Kidney Donor Risk Index (KDRI) and the UK KDRI were calculated for each donor. Recipients who were allocated these grafts were characterised, and the Hennepin Transplant Risk Score and the Kidney Transplant Morbidity Index (KTMI) were calculated. The median (interquartile range) KDRI was 1.2 (0.9 - 1.6), confirming that low- to average-risk donors were being utilised. Similarly, the median UK KDRI was 0.9 (0.8 - 1.2). Both these scores performed poorly in predicting graft and patient survival, with a C-statistic of 0.5. Renal recipient risk scores also demonstrated low- to average-risk patients being transplanted, with a median Hennepin score of 2 - 4 points and a KTMI of 2 points. These recipient scores predict increased recipient mortality at high scores, albeit with low sensitivity, and were not significantly associated with graft survival. Deceased-donor and renal recipient risk scores commonly used internationally performed poorly in predicting graft survival in our cohort, and should be used with caution in the SA setting. A conservative approach to organ donor referral and utilisation as well as renal transplant recipient listing was noted.

Infra-inguinal bypass surgery vs endovascular revascularization for chronic limb-threatening ischemia in average- and high-risk patients

ObjectiveThis study aimed to evaluate treatment outcomes after bypass surgery or endovascular therapy (EVT) in average- and high-risk patients with chronic limb-threatening ischemia (CLTI). MethodsWe retrospectively analyzed multicenter data of patients who underwent infra-inguinal revascularization for CLTI between 2015 and 2022. A high-risk patient was defined as one with estimated 30-day mortality rate ≥5% or 2-year survival rate ≤50%, as determined by the Surgical Reconstruction vs Peripheral Intervention in Patients With Critical Limb Ischemia (SPINACH) calculator. The amputation-free survival (AFS), limb salvage (LS), wound healing, and 30-day mortality were compared separately for the average- and high-risk patients between the bypass and EVT with propensity score matching. ResultsWe analyzed 239 and 31 propensity score-matched pairs in the average- and high-risk patients with CLTI. In the average-risk patients, the 2-year AFS and LS rates were 78.1% and 94.4% in the bypass group and 63.0% and 87.7% in the EVT group (P < .001 and P = .007), respectively. The 1-year wound healing rates were 88.6% in the bypass group and 76.8% in the EVT group, respectively (P < .001). The 30-day mortality was 0.8% in the bypass surgery and 0.8% in the EVT group (P = .996). In the high-risk patients, there was no differences in the AFS, LS, and wound healing between the groups (P = .591, P = .148, and P = .074). The 30-day mortality was 3.2% in the bypass group and 3.2% in the EVT group (P = .991). ConclusionsBypass surgery is superior to EVT with respect to the AFS, LS, and wound healing in the average-risk patients. EVT is a feasible first-line treatment strategy for high-risk patients with CLTI undergoing revascularization, based on the lack of significant differences in the 2-year AFS rate, between the bypass surgery and EVT cohorts.

Abstract 1263: Interim results from a large-scale, prospective cohort study (JINLING) for multi-cancer early detection test in average-risk asymptomatic patients

Abstract Background: Previously, we reported that a multi-cancer early detection (MCED) test CanScan, which utilizes plasma cfDNA genome-wide fragmentomics-related features that can detect cancer signals and tissue of origin (TOO) signals across thirteen cancer types at 99% specificity in individuals with cancer. Here, we report the interim results of a first large-scale prospective clinical study in an asymptomatic population with average risk of cancer, the JINLING Cohort (NCT06011694). Methods: This ongoing prospective clinical study is enrolling participants aged between 45 and 75 years old without cancer-related symptoms, initiated in June 2022. Each participant will undergo peripheral blood collection for CanScan test and annual routine physical exams once a year for three consecutive years, with an additional two years of follow-up. The primary objective of the study was to evaluate the diagnostic performance of the CanScan test in the early detection of multiple cancers. Secondary objectives include the evaluation of TOO accuracy, its efficiency and clinical utility, lead-time relative to clinical diagnosis, and participants' attitudes and adherence to this test compared to standard care screening methods. Results: By June 2023, a total of 3724 participants with analyzable samples were included in the analysis. At the data cut off time of Sept 2023, 29 participants were clinically diagnosed with cancer, including 8 that were not in the 13 targeted cancer types. The majority of the cancers were found in the early stages (Stage I or II; 89.6%, 26/29). The CanScan test detected a cancer signal at a sensitivity of 55.2% (16/29; stage I: 10/21, 47.6%; stage II: 4/5, 80.0%; stage III: 2/3, 66.7%). For detected cancers, the prediction accuracy of the top predicted origin was 61.5% (95% CI [38.5%,84.6%]; stage I: 62.5% [5/8]; stage II: 1/3, 33.3%; stage III: 2/2, 100%). The accuracy was 84.6% (95% CI [61.5%,100.0%]; I: 87.5% [7/8]; II: 66.7% [2/3]; III: 100.0% [2/2]) when taking into account the top two predicted origins. Specificity was 97.9% (3619/3695) in non-cancer participants. Conclusions: In this one-year interim analysis of the large-scale, prospective, clinical cohort study, we investigated the efficacy of the MCED test within an asymptomatic population with an average-risk of cancer. the CanScan test demonstrates capability in detecting a wide range of cancer types and predicting TOO at early stages, highlighting an exceptional level of sensitivity and accuracy while maintaining a high level of specificity. Therefore, the MCED test holds significant potential for early cancer screening in asymptomatic populations, potentially transforming preventative healthcare and improving patient outcomes. Citation Format: Shanshan Yang, Hua Bao, Xiaoxi Chen, Min Wu, Shiting Tang, Ruowei Yang, Dongqin Zhu, Xuxiaochen Wu, Wanxiangfu Tang, Shuang Chang, Peng He, Xiuxiu Xu, Ya Jiang, Shuyu Wu, Sisi Liu, Xian Zhang, Xue Wu, Yang Shao. Interim results from a large-scale, prospective cohort study (JINLING) for multi-cancer early detection test in average-risk asymptomatic patients [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2024; Part 1 (Regular Abstracts); 2024 Apr 5-10; San Diego, CA. Philadelphia (PA): AACR; Cancer Res 2024;84(6_Suppl):Abstract nr 1263.

Exploratory Analysis of Concordance Between Clinician-Collected and Self-Sampled Human Papillomavirus Tests in a Small Cohort of Average- and High-Risk Patients.

Cervical cancer screening rates have stagnated, but self-sampling modalities have the potential to increase uptake. This study compares the test characteristics of self-sampled high-risk human papillomavirus (hrHPV) tests with clinician-collected hrHPV tests in average-risk (i.e., undergoing routine screening) and high-risk patients (i.e., receiving follow-up after abnormal screening results). In this cross-sectional study, a relatively small cohort of average-risk (n = 35) and high-risk (n = 12) participants completed both clinician-collected and self-sampled hrHPV testing, along with a brief phone survey. We assessed hrHPV positivity, concordance, positive predictive value (PPV), negative predictive value (NPV), sensitivity, and specificity across both methods (for types 16, 18, or other hrHPV). We also explored the relationship between test concordance and sociodemographic/behavioral factors. Among average-risk participants, hrHPV positivity was 6% for both test methods (i.e., hrHPV-positive cases: n = 2), resulting in reported concordance, PPV, NPV, sensitivity, and specificity of 100%. Among high-risk participants, hrHPV positivity was 100% for clinician-collected tests but only 67% for self-sampled tests, showing varied concordance and sensitivity. Concordance was not associated with sociodemographic or behavioral factors. Self-sampled hrHPV testing demonstrated high accuracy for average-risk patients in this exploratory study. However, its performance was less consistent in high-risk patients who had already received an abnormal screening result, which could be attributed to spontaneous viral clearance over time. The limited number of participants, particularly HPV-positive cases, suggests caution in interpreting these results. Further research with larger cohorts is necessary to validate these findings and to explore the integration of self-sampled hrHPV testing into routine clinical care, particularly for patients with a history of cervical abnormalities. NCT04591977, NCT04585243.