Monitoring Of Cancer Patients Research Articles

Longitudinal on-treatment circulating tumor DNA as a biomarker for real-time dynamic risk monitoring in cancer patients: The EP-SEASON study

Recurrence risks of cancer patient can change during treatment as a result of treatment-related tumor evolution. However, biomarkers that can monitor these changes are lacking. Here, we investigated whether tracking circulating tumor DNA (ctDNA) dynamics through liquid biopsy can inform real-time recurrence risk. Nasopharyngeal carcinoma (NPC) provides an ideal model where cell-free Epstein-Barr virus (EBV) DNA (cfEBV DNA), a ctDNA, can be sensitively detected. We conducted the EP-SEASON study (NCT03855020) and prospectively recruited 1,000 NPC patients undergoing per-protocol cfEBV DNA assessments at 11 time points and receiving sequential chemo-radiotherapy. Longitudinal cfEBV DNA displayed distinct patterns during neoadjuvant chemotherapy and radiotherapy. Despite the prognostic significance of cfEBV DNA at each time point, real-time recurrence risks changed in sync with cfEBV DNA dynamics. Furthermore, we identified phenotypes of whole-course ctDNA changing dynamics associated with different survival outcomes. In conclusion, tracking longitudinal on-treatment ctDNA can forecast real-time recurrence risk, facilitating risk-adapted, individualized patient management.

Quantification method of ctDNA using cell-free DNA methylation profile for noninvasive screening and monitoring of colon cancer

BackgroundColon cancer ranks as the second most lethal form of cancer globally. In recent years, there has been active investigation into using the methylation profile of circulating tumor DNA (ctDNA), derived from blood, as a promising indicator for diagnosing and monitoring colon cancer.ResultsWe propose a liquid biopsy-based epigenetic method developed by utilizing 49 patients and 260 healthy controls methylation profile data to screen and monitor colon cancer. Our method initially identified 901 colon cancer-specific hypermethylated (CaSH) regions in the tissues of the 49 cancer patients. We then used these CaSH regions to accurately quantify the amount of circulating tumor DNA (ctDNA) in the blood samples of these same patients, utilizing cell-free DNA methylation profiles. Notably, the methylation profiles of ctDNA in the blood exhibited high sensitivity (82%) and specificity (93%) in distinguishing patients with colon cancer from the control group, with an area under the curve of 0.903. Furthermore, we confirm that our method for ctDNA quantification is effective for monitoring cancer patients and can serve as a valuable tool for postoperative prognosis.ConclusionsThis study demonstrated a successful application of the quantification of ctDNA among cfDNA using the original cancer tissue-derived CaSH region for screening and monitoring colon cancer.

Core outcome Set for Cardio-oncology (COS-CO): development of a set of outcomes for the cardiovascular assessment and monitoring of cancer patients and survivors.

There is an increasing awareness of the evidence-based selection of outcomes to be measured in clinical trials and clinical practice. Currently, there is no core outcome set (COS) for cardio-oncology, which may hinder the (inter)national comparison of the effectiveness of research and the quality of cardio-oncology care. The aim of this study is to develop a standard and pragmatic patient-centred outcome set to assess and monitor cancer patients and survivors at risk of or with cardiovascular diseases. A list of outcome domains was generated through a review of registries and guidelines, and six patient interviews. The project team reviewed and refined the outcome domains prior to starting a two-round Delphi procedure conducted between January-June 2022. The panellists, including healthcare providers and researchers, were invited to rate the importance of the outcomes. 26 experts from 11 countries rated a list of 93 outcomes (round 1) and 63 outcomes (round 2) to gain consensus on a list of outcome measures, and of demographic factors, health status and treatment variables. The final COS includes 15 outcome measures, reflecting four core areas: life impact (n=2), pathophysiological manifestations (n=9), resource use/economic impact (n=1), and mortality/survival (n=3). Next, six demographic factors, 21 health status, three cardiovascular and nine cancer variables were included. This is the first international development of a COS for cardio-oncology. This set aims to facilitate (inter)national comparison in cardio-oncology care, using standardised parameters and meaningful patient-centred outcomes for research and quality of care assessments.

Remote electrocardiogram monitoring in cancer patients for detecting cardiotoxicity. Case report

Cardiotoxicity is the direct adverse effect of anticancer agents on the function or structure of the heart, occurring both during treatment and many years later. The manifestations of cardiotoxicity can be very different: heart failure, coronary heart disease, cardiomyopathy, myocarditis, pericarditis, and arrhythmias, including atrial fibrillation (AF). The incidence of AF in the cancer patient population during therapy is 20–30%. Current options of remote electrocardiogram monitoring ensure the timely detection and treatment of AF in cancer patients, including the administration of anticoagulants. The article presents a clinical case of a 59-year-old patient with squamous cell carcinoma of the lower third of the esophagus after the first course of the TPF polychemotherapy regimen (docetaxel, cisplatin, 5-fluorouracil) with AF detected using a single-channel electrocardiogram monitor in a smartphone case.

Simultaneous determination of 11 oral targeted antineoplastic drugs and 2 active metabolites by LC-MS/MS in human plasma and its application to therapeutic drug monitoring in cancer patients

Interindividual exposure differences have been identified in oral targeted antineoplastic drugs (OADs) owing to the pharmacogenetic background of the patients and their susceptibility to multiple factors, resulting in insufficient efficacy or adverse effects. Therapeutic drug monitoring (TDM) can prevent sub-optimal concentrations of OADs and improve their clinical treatment. This study aimed to develop and validate an LC-MS/MS method for the simultaneous quantification of 11 OADs (gefitinib, imatinib, lenvatinib, regorafenib, everolimus, osimertinib, sunitinib, tamoxifen, lapatinib, fruquintinib and sorafenib) and 2 active metabolites (N-desethyl sunitinib and Z-endoxifen) in human plasma. Protein precipitation was used to extract OADs from the plasma samples. Chromatographic separation was performed using an Eclipse XDB-C18 (4.6 × 150 mm, 5 μm) column with a gradient elution of the mobile phase composed of 2 mM ammonium acetate with 0.1 % formic acid in water (solvent A) and methanol (solvent B) at a flow rate of 0.8 mL/min. Mass analysis was performed using positive ion mode electrospray ionization in multiple-reaction monitoring mode. The developed method was validated following FDA bioanalytical guidelines. The calibration curves were linear over the range of 2–400 ng/mL for gefitinib, imatinib, lenvatinib, regorafenib, and everolimus; 1–200 ng/mL for osimertinib, sunitinib, N-desethyl sunitinib, tamoxifen, and Z-endoxifen; and 5–1000 ng/mL for lapatinib, fruquintinib, and sorafenib, with all coefficients of correlation above 0.99. The intra- and inter-day imprecision was below 12.81 %. This method was successfully applied to the routine TDM of gefitinib, lenvatinib, regorafenib, osimertinib, fruquintinib, and sorafenib to optimize the dosage regimens.

Effects on Quality of Life of a Telemonitoring Platform amongst Patients with Cancer (EQUALITE): A Randomized Trial Protocol.

Cancer, a pervasive global health challenge, necessitates chemotherapy or radiotherapy treatments for many prevalent forms. However, traditional follow-up approaches encounter limitations, exacerbated by the recent COVID-19 pandemic. Consequently, telemonitoring has emerged as a promising solution, although its clinical implementation lacks comprehensive evidence. This report depicts the methodology of a randomized trial which aims to investigate whether leveraging a smartphone app called Contigo for disease monitoring enhances self-reported quality of life among patients with various solid cancers compared to standard care. Secondary objectives encompass evaluating the app's impact on depressive symptoms and assessing adherence to in-person appointments. Randomization will be performed independently using an allocation sequence that will be kept concealed from clinical investigators. Contigo offers two primary functions: monitoring cancer patients' progress and providing educational content to assist patients in managing common clinical situations related to their disease. The study will assess outcomes such as quality of life changes and depressive symptom development using validated scales, and adherence to in-person appointments. Specific scales include the EuroQol Group's EQ-5D questionnaire and the Patient Health Questionnaire (PHQ-9). We hypothesize that the use of Contigo will assist and empower patients receiving cancer treatment, which will translate to better quality of life scores and a reduced incidence of depressive symptoms. All analyses will be undertaken with the intention-to-treat principle by a statistician unaware of treatment allocation. This trial is registered in ClinicalTrials under the registration number NCT06086990.

Use of improved memory type control charts for monitoring cancer patients recovery time censored data

Control charts are a statistical approach for monitoring cancer data that can assist discover patterns, trends, and unusual deviations in cancer-related data across time. To detect deviations from predicted patterns, control charts are extensively used in quality control and process management. Control charts may be used to track numerous parameters in cancer data, such as incidence rates, death rates, survival time, recovery time, and other related indicators. In this study, CDEC chart is proposed to monitor the cancer patients recovery time censored data. This paper presents a composite dual exponentially weighted moving average Cumulative sum (CDEC) control chart for monitoring cancer patients recovery time censored data. This approach seeks to detect changes in the mean recovery time of cancer patients which usually follows Weibull lifetimes. The results are calculated using type I censored data under known and estimated parameter conditions. We combine the conditional expected value (CEV) and conditional median (CM) approaches, which are extensively used in statistical analysis to determine the central tendency of a dataset, to create an efficient control chart. The suggested chart's performance is assessed using the average run length (ARL), which evaluates how efficiently the chart can detect a change in the process mean. The CDEC chart is compared to existing control charts. A simulation study and a real-world data set related to cancer patients recovery time censored data is used for results illustration. The proposed CDEC control chart is developed for the data monitoring when complete information about the patients are not available. So, instead of doping the patients information we can used the proposed chart to monitor the patients information even if it is censored. The authors conclude that the suggested CDEC chart is more efficient than competitor control charts for monitoring cancer patients recovery time censored data. Overall, this study introduces an efficient new approach for cancer patients recovery time censored data, which might have significant effect on quality control and process improvement across a wide range of healthcare and medical studies.

Abstract C028: Using novel multiomic plasma profiling from liquid biopsies to identify potential signatures for disease diagnostics in late-stage non-small cell lung cancer (NSCLC) in Trinidad and Tobago

Abstract Lung cancer is the leading cause of cancer-associated deaths in North America, with the vast majority being non-small cell lung cancer (NSCLC) with a five-year survival rate of only 24%. Non-invasive discovery of biomarkers associated with early-diagnosis of NSCLC can enable precision oncology efforts using liquid biopsy-based multiomic profiling of plasma cell-free DNA. Although tissue biopsies are currently the gold standard for tumor profiling, this method presents many limitations since these are invasive, risky, and sometimes hard to obtain as well as only giving a limited tumor profile. Blood-based, biomarker directed liquid biopsies provide a less-invasive, more robust approach to interrogate both tumor- and non-tumor-derived signals. Liquid biopsies can delineate complex tumoral genomic and proteomic profiles throughout tumor evolution and are increasingly used for cancer diagnostics that enables a precision oncology approach. We intend to examine 30 stage III-IV NSCLC pre-surgical patients and collect plasma samples. Cell-free DNA (cfDNA) will be extracted from plasma, and next-generation sequencing (NGS) performed as well as comparative traditional diagnostics. Through the analysis of tumor-specific alterations used as biomarkers, including single nucleotide variants (SNVs), insertions, deletions, copy number variations (CNVs), and methylation alterations we intend to identify tumor-derived DNA—ctDNA, among the total pool of cfDNA. Analysis of cancer genotyping for diagnostic purposes will also be compared to accuracy of traditional, imaging and tissue-based techniques. Using liquid biopsies offer opportunities to improve the surveillance of cancer patients during treatment and would supplement current diagnosis and tumor profiling strategies previously not readily available in Trinidad and Tobago. There are a vast number of advantages to use molecular biomarkers like liquid biopsies in diagnosis and tumor profiling as well as to monitor cancer patients, providing early information regarding disease evolution and treatment efficacy, and reorient treatment strategies rapidly, thereby improving clinical oncology outcomes. With the development of both experimental protocols and computational methods dedicated to liquid biopsy, the implementation of multi-omics strategies into the clinical workflow, especially in an under-performing clinical diagnostic system, will benefit the clinical management of cancers including decision-making guidance and patient outcome improvement in the underserved communities of Trinidad and Tobago. Citation Format: Samuel M. West, Nicole Ramlachan. Using novel multiomic plasma profiling from liquid biopsies to identify potential signatures for disease diagnostics in late-stage non-small cell lung cancer (NSCLC) in Trinidad and Tobago [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 C028.

The utility of liquid biopsy in clinical genetic diagnosis of cancer and monogenic mosaic disorders.

Liquid biopsy for minimally invasive diagnosis and monitoring of cancer patients is progressing toward routine clinical practice. With the implementation of highly sensitive next-generation sequencing (NGS) based assays for the analysis of cfDNA, however, consideration of the utility of liquid biopsy for clinical genetic testing is critical. While the focus of liquid biopsy for cancer diagnosis is the detection of circulating tumor DNA (ctDNA) as a fraction of total cell-free DNA (cfDNA), cfDNA analysis reveals both somatic mosaic tumor and germline variants and clonal hematopoiesis. Here we outline advantages and limitations of mosaic and germline variant detection as well as the impact of clonal hematopoiesis on liquid biopsy in cancer diagnosis. We also evaluate the potential of cfDNA analysis for the molecular diagnosis of monogenic mosaic disorders.

Tumor-Agnostic Circulating Tumor DNA Testing for Monitoring Muscle-Invasive Bladder Cancer

Circulating tumor DNA (ctDNA) has recently emerged as a real-time prognostic and predictive biomarker for monitoring cancer patients. Here, we aimed to ascertain whether tumor-agnostic ctDNA testing would be a feasible strategy to monitor disease progression and therapeutic response in muscle-invasive bladder cancer (MIBC) patients after radical cystectomy (RC). Forty-two MIBC patients who underwent RC were prospectively included. Blood samples from these patients were collected at different follow-up time points. Two specific mutations (TERT c.1-124C>T and ATM c.1236-2A>T) were analyzed in the patients’ plasma samples by droplet digital PCR to determine their ctDNA status. During a median follow-up of 21 months, 24% of patients progressed in a median of six months. ctDNA status was identified as a prognostic biomarker of tumor progression before RC and 4 and 12 months later (HR 6.774, HR 3.673, and HR 30.865, respectively; p < 0.05). Lastly, dynamic changes in ctDNA status between baseline and four months later were significantly associated with patient outcomes (p = 0.045). In conclusion, longitudinal ctDNA analysis using a tumor-agnostic approach is a potential tool for monitoring MIBC patients after RC. The implementation of this testing in a clinical setting could improve disease management and patients’ outcomes.

B-368 Non-invasive Longitudinal Analysis of Cancer Signal to Monitor Disease Progression and Responses to Treatment

Abstract Background Multi-cancer early detection products are poised to change cancer treatment and survival. However, current applications lack the ability to translate analytical findings to clinical outcomes. Quantitatively tracking cancer signals is the next frontier for early cancer detection and data-driven intervention. Harbinger Health has pioneered a platform that combines novel epigenomic insights with artificial intelligence to detect cancer and monitor signal over time to track disease progression and/or response to treatment. Methods We designed a comprehensive enrichment panel (17.8 Mb) which provides simultaneous methylation and mutational state for cancer and tissue-of-origin informative regions as well as a panel of tumor suppressor genes and oncogenic drivers. We also defined the most significant methylation motifs (MMs) that contribute to pan-cancer signal and developed an algorithm to estimate the amount of tumor-derived reads in a cell-free DNA (cfDNA) sample. To verify our methodology, we performed whole exome sequencing (WES) for a cohort of 46 patients with matched FFPE and cfDNA and compared variant allele frequency of somatic mutations to tumor content estimates from MMs. We used this tumor content (%TC) estimate to quantify signal over time and monitor dynamic changes in the tumor. Simultaneously, we tracked orthogonal mutations across treatment. To clinically assess our quantitative analysis, we sourced longitudinal samples of 21 cancer patients over the course of treatment with four timepoints, averaging 38 days apart. Timepoint 0 (TP0) was before any treatment, while TP1, TP2, and TP3 were taken before subsequent treatment. For most timepoints, we had endpoint RECIST data which identified n = 8 samples as progressive disease (PD), n = 1 as stable disease (SD), n = 9 as partial response (PR), and n = 3 as complete response (CR). We also sourced 21 non-cancer subjects with two timepoints, 60 days apart. All samples across these timepoints were captured with the 17.8 Mb panel and analysis was done to assess longitudinal tracking—predict prognosis, identify minimal residual disease (MRD), and/or detect disease progression. Results We confirmed that our %TC estimates derived using MMs were highly correlated to estimates derived using WES. We therefore utilized our methylation data to estimate %TC for all timepoints across treatment. The %TC ranged from 0.02% to 60%, with Stage IV disease showing the greatest tumor burden, as expected. Notably, %TC showed dynamic fold-changes during treatment, with differential levels between response groups and non-cancers. In a small subset that included three Stage IV prostate cancer patients with high initial %TC, our biomarkers were able to identify one patient that was reported PR but showed an increase of 18.9% tumor content, indicating disease progression. This patient was deceased at last follow-up. [Additional data to be reported.] Conclusion Our analytical approach of identifying %TC based on Harbinger Health’s proprietary enrichment panel was successful in quantitatively monitoring cancer patients through treatment and disease progression. Our data can provide valuable insights to help clinicians make more informed decisions (e.g. increased monitoring or interventions) about patient care. Further development of techniques enriching specifically for these MMs are in progress.

Clinical Significance of PD-L1 Status in Circulating Tumor Cells for Cancer Management during Immunotherapy.

The approval of monoclonal antibodies against programmed death-ligand 1 (PD-L1) and programmed cell death protein (PD1) has changed the landscape of cancer treatment. To date, many immune checkpoint inhibitors (ICIs) have been approved by the FDA for the treatment of metastatic cancer as well as locally recurrent advanced cancer. However, immune-related adverse events (irAEs) of ICIs highlight the need for biomarker analysis with strong predictive value. Liquid biopsy is an important tool for clinical oncologists to monitor cancer patients and administer or change appropriate therapy. CTCs frequently express PD-L1, and this constitutes a clinically useful and non-invasive method to assess PD-L1 status in real-time. This review summarizes all the latest findings about the clinical significance of CTC for the management of cancer patients during the administration of immunotherapy and mainly focuses on the assessment of PD-L1 expression in CTCs.

Incident Diabetes By Obesity-Related Cancer Status and Cancer Treatment Type: A Prospective Study Using Electronic Medical Records Data

Background: Diabetes has been associated with an increased risk of the development of multiple cancers, however evidence for development of diabetes after cancer diagnosis is limited. Methods: Using data on 7,702 cancer patients treated at the Huntsman Cancer Institute, a comprehensive cancer center in Utah, we examined the association of systemic cancer treatments (chemotherapy, immunotherapy, hormone therapy, and corticosteroids) and obesity-related cancer (ORC) status with the development of diabetes after cancer diagnosis. Cox proportional-hazards models adjusting for relevant covariates [age, sex, race, body mass index at cancer diagnosis, and ORC status (in treatment–related models only)] were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). Diabetes, cancer treatments, and cancer sites were identified using ICD codes and tumor histology. Results: 975(12.7%) cancer patients had incident diabetes (723 type-2 diabetes), and the mean time to diabetes diagnosis was 4.4 years after cancer diagnosis. 35.1% cancer patients received chemotherapy, 11.8% received immunotherapy, 19.5% received hormone therapy, 38.8% received corticosteroids, and 40.8% were diagnosed with an ORC. ORC patients and corticosteroid users had a statistically significant elevated risk of new-onset diabetes [HR (95% CI) = 1.43 (1.24–1.65) and 1.29 (1.13–1.47), respectively] compared to patients with a non-ORC and non-users of corticosteroids. Interestingly, patients who received chemotherapy or hormone therapy had a statistically significant lower risk of new-onset diabetes [HR(95% CI) = 0.69 (0.60–0.79) and 0.68 (0.58–0.81), respectively] compared to patients who did not receive these treatments. Stratified analyses evaluating death as a competing risk factor are ongoing. Conclusion: We observed statistically significant 1.43-times and 1.29-times increased risk of incident diabetes after cancer diagnosis in ORC patients and corticosteroid users. These results suggest that certain cancer treatments may increase diabetes risk. As monitoring cancer patients for new onset diabetes is currently not a clinical standard, understanding diabetes risk in cancer patients can inform strategies for monitoring cancer patients to prevent diabetes development.

Analysis of the applicability of the mHealth ALIBIRD platform and its impact on the follow-up of patients with lung cancer.

e24050 Background: Lung cancer is associated with a wide symptom burden. Often, patient's symptoms are inadequately captured during routine visits. For this reason, there is an increasing interest in developing effective approaches for patient-reported symptom management at home. Emerging evidence suggests that this strategy should lead to reducing toxicity and emergency room visits and improving quality of life. In the context of the ALIBIRD2020-CM project, we developed the mHealth ALIBIRD platform (mHAP) to remotely monitoring cancer patients. Methods: The mHAP implemented consists of a mobile application for patients and a web tool for the clinical team. Through the mobile application, patients record symptoms, toxicities, and lifestyle variables such as diet, physical activity and sleep through Fitbit wearables. Based on patient-reported outcomes (PRO), patient-reported outcome measures (PROM), patient gut microbiome and nutrigenomics data, this platform provides personalised recommendations and advice. Clinicians can visualise patient data, resolve symptom alerts, and make clinical-therapeutic decisions. A single-branch interventional pilot study was carried out at Hospital Infanta Sofía and approved by the Ethics Committee (HULP PI-4735). The primary outcome was to assess the mHAP, usability. The secondary outcome was to assess the clinical impact of the tool. Results: Twenty patients with stage IV thoracic neoplasms under active treatment participated for 6 months with 10 face-to-face visits for oncological and nutritional control. Anthropometric parameters were measured at each nutritional control, and muscle ultrasound was performed on visits 1, 5, and 10. Our results demonstrate a high level of user satisfaction with mHAP. A total of 679 symptoms were captured by mHAP, 96 alerts were detected and resolved (only 3 patients were referred to ER) and an early detection of a progression was done. The two main categories of severe toxicities recorded through the PROCTCAE questionnaire were the sensation of pain (25%) and asthenia and quality of rest (23%). There was an increase in the trend of moderate physical activity and adherence to the Mediterranean diet (21.4%) from baseline. Nutrigenetic analyses have led to the detection of 5 lactose intolerant patients and 4 patients with intermediate tolerance to gluten. Preliminary results from gut microbiome analysis indicate that 75% of the patients have dysbiosis. At the last visit, the HADS questionnaire showed 7% of cases with anxiety problems and 14% with depression. Conclusions: The findings obtained so far relate the mHAP to a favourable clinical impact, high usability and satisfaction. mHAP promotes healthy lifestyle and patient´empowerment, and supports clinicians for personalized recommendations, therapeutic adjustments in medication and nutritional supplementation as well as referrals to other specialists.

Detection and Molecular Characterization of Circulating Tumour Cells: Challenges for the Clinical Setting.

Over the last decade, liquid biopsy has gained much attention as a powerful tool in personalized medicine since it enables monitoring cancer evolution and follow-up of cancer patients in real time. Through minimally invasive procedures, liquid biopsy provides important information through the analysis of circulating tumour cells (CTCs) and circulating tumour-derived material, such as circulating tumour DNA (ctDNA), circulating miRNAs (cfmiRNAs) and extracellular vehicles (EVs). CTC analysis has already had an important impact on the prognosis, detection of minimal residual disease (MRD), treatment selection and monitoring of cancer patients. Numerous clinical trials nowadays include a liquid biopsy arm. CTC analysis is now an exponentially expanding field in almost all types of solid cancers. Functional studies, mainly based on CTC-derived cell-lines and CTC-derived explants (CDx), provide important insights into the metastatic process. The purpose of this review is to summarize the latest findings on the clinical significance of CTCs for the management of cancer patients, covering the last four years. This review focuses on providing a comprehensive overview of CTC analysis in breast, prostate and non-small-cell lung cancer. The unique potential of CTC single-cell analysis for understanding metastasis biology, and the importance of quality control and standardization of methodologies used in this field, is also discussed.

Abstract 741: Incident diabetes by obesity-related cancer status and cancer treatment type

Abstract Background: Diabetes has been associated with an increased risk of the development of multiple cancers, however, evidence for development of diabetes after cancer diagnosis is limited. Methods: Using data on 7,702 cancer patients treated at the Huntsman Cancer Institute, a comprehensive cancer center in Utah, we examined the association of systemic cancer treatments (chemotherapy, immunotherapy, hormone therapy, and corticosteroids) and obesity-related cancer (ORC) status (presence of breast, colorectal, ovarian, endometrial, kidney, thyroid, meningioma, multiple myeloma, gallbladder, gastric cardia, esophageal adenocarcinoma, liver, or pancreatic cancer), with the development of diabetes after cancer diagnosis. Cox proportional-hazards regression models adjusting for relevant covariates [age, sex, race, body mass index at cancer diagnosis, and ORC status (in treatment-related models only)] were used to calculate hazard ratios (HR) and 95% confidence intervals (CI). Diabetes, cancer treatment type, and cancer sites were identified using ICD codes and tumor histology. Results: 975(12.7%) cancer patients had incident diabetes (723 of which were type-2 diabetes), and the average time to diabetes diagnosis after cancer diagnosis was 4.4 years. 35.1% used chemotherapy, 11.8% used immunotherapy, 19.5% used hormone therapy, 38.8% used corticosteroids, and 40.8% had an ORC. ORC patients and patients who used corticosteroids had a statistically significant higher hazard of new-onset diabetes [HR(95% CI) 1.43(1.24-1.65), 1.29(1.13-1.47), respectively] compared to patients with a non-ORC and patients who did not use corticosteroids, respectively. Interestingly, patients who received chemotherapy or hormone therapy had a statistically significant lower hazard of new-onset diabetes [HR(95% CI) 0.69(0.60-0.79), 0.68(0.58-0.81), respectively] compared to patients who did not receive chemotherapy or hormone therapy, respectively. Analyses by cancer site and diabetes type and evaluating death as a competing risk factor are ongoing. Conclusions: We observed statistically significant 1.43-times and 1.29-times higher hazards of incident diabetes after cancer diagnosis in ORC patients and corticosteroid users. These results suggest that certain cancers and cancer treatments may increase diabetes risk. As monitoring cancer patients for persistent hyperglycemia and diabetes is currently not a clinical standard, understanding the risk of chronic diseases, including diabetes, can inform strategies to monitor patients and decrease disease burden in this vulnerable population. Citation Format: Maci Winn, Svenja Pauleck, Richard Viskochil, Stephanie Richardson, Michelle Litchman, Howard Colman, Neli Ulrich, Siwen Hu-Lieskovan, Mary Playdon, Sheetal Hardikar. Incident diabetes by obesity-related cancer status and cancer treatment type [abstract]. In: Proceedings of the American Association for Cancer Research Annual Meeting 2023; Part 1 (Regular and Invited Abstracts); 2023 Apr 14-19; Orlando, FL. Philadelphia (PA): AACR; Cancer Res 2023;83(7_Suppl):Abstract nr 741.

The importance of CA 72-4 and CA 19-9 dosing in gastric cancer.

Serological analysis of tumor markers has emerged as a non-invasive method for monitoring cancer patients, including tumor recurrence and response to treatment. Tumor markers have the potential to aid in both the diagnosis and prognosis of cancer, but their most important role currently lies in the monitoring of tumor progression. Tumor markers can also provide valuable information on treatment effectiveness, with changes in plasma values indicating tumor regression or progression. This research aimed to investigate the correlation between the serum detection values of three tumor markers - CEA, CA 19-9, and CA 72-4 - and their utility in the diagnosis and prognosis of patients with gastric cancer. The study seeks to uncover the relationship between these tumor markers and the evolution of gastric cancer, providing insights into their potential use in clinical practice.

Analytical exploratory tool for healthcare professionals to monitor cancer patients' progress.

Cancer is a primary public concern in the European continent. Due to the large case numbers and survival rates, a significant population is living with cancer needs. Consequently, health professionals must deal with complex treatment decision-making processes. In this context, a large quantity of data is collected during cancer care delivery. Once collected, these data are complex for health professionals to access to support clinical decision-making and performance review. There is a need for innovative tools that make clinical data more accessible to support cancer health professionals in these activities. Following a co-creation, an interactive approach thanks to the Interactive Process Mining paradigm, and data from a tertiary hospital, we developed an exploratory tool to present cancer patients' progress over time. This work aims to collect and report the process of developing an exploratory analytical Interactive Process Mining tool with clinical relevance for healthcare professionals for monitoring cancer patients' care processes in the context of the LifeChamps project together with a graphical and navigable Process Indicator in the context of prostate cancer patients. The tool presented includes Process Mining techniques to infer actual processes and present understandable results visually and navigable, looking for different types of patients, trajectories, and behaviors.

CTC-5: A novel digital pathology approach to characterise circulating tumour cell biodiversity

Metastatic progression and tumor evolution complicates the clinical management of cancer patients. Circulating tumor cell (CTC) characterization is a growing discipline that aims to elucidate tumor metastasis and evolution processes. CTCs offer the clinical potential to monitor cancer patients for therapy response, disease relapse, and screen ‘at risk' groups for the onset of malignancy. However, such clinical utility is currently limited to breast, prostate, and colorectal cancer patients. Further understanding of the basic CTC biology of other malignancies is required to progress them towards clinical utility. Unfortunately, such basic clinical research is often limited by restrictive characterization methods and high-cost barrier to entry for CTC isolation and imaging infrastructure. As experimental clinical results on applications of CTC are accumulating, it is becoming clear that a two-tier system of CTC isolation and characterization is required. The first tier is to facilitate basic research into CTC characterization. This basic research then informs a second tier specialised in clinical prognostic and diagnostic testing.This study presented in this manuscript describes the development and application of a low-cost, CTC isolation and characterization pipeline; CTC-5. This approach uses an established ‘isolation by size’ approach (ScreenCell Cyto) and combines histochemical morphology stains and multiparametric immunofluorescence on the same isolated CTCs. This enables capture and characterization of CTCs independent of biomarker-based pre-selection and accommodates both single CTCs and clusters of CTCs. Additionally, the developed open-source software is provided to facilitate the synchronization of microscopy data from multiple sources (https://github.com/CTC5/). This enables high parameter histochemical and immunofluorescent analysis of CTCs with existing microscopy infrastructure without investment in CTC specific imaging hardware.Our approach confirmed by the number of successful tests represents a potential major advance towards highly accessible low-cost technology aiming at the basic research tier of CTC isolation and characterization. The biomarker independent approach facilitates closing the gap between malignancies with poorly, and well-defined CTC phenotypes. As is currently the case for some of the most commonly occurring breast, prostate and colorectal cancers, such advances will ultimately benefit the patient, as early detection of relapse or onset of malignancy strongly correlates with their prognosis.

Real-World Experience of Monitoring Practice of Endocrinopathies Associated with the Use of Novel Targeted Therapies among Patients with Solid Tumors.

Cancer treatments have gradually evolved into targeted molecular therapies characterized by a unique mechanism of action instead of non-specific cytotoxic chemotherapies. However, they have unique safety concerns. For instance, endocrinopathies, which are defined as unfavorable metabolic alterations including thyroid disorders, hyperglycemia, dyslipidemia, and adrenal insufficiency necessitate additional monitoring. The aim of this study was to assess the prevalence of monitoring errors and develop strategies for monitoring cancer patients who receive targeted therapies. A retrospective chart review was used to assess the prevalence of monitoring errors of endocrinopathies among cancer patients who received targeted therapies over one year. All of the adult cancer patients diagnosed with a solid tumor who received targeted therapies were included. The primary outcome was to determine the prevalence of monitoring errors of endocrinopathies. The secondary outcomes were to assess the incidences of endocrinopathies and referral practice to endocrinology services. A total of 128 adult patients with solid tumors were involved. The primary outcome revealed a total of 148 monitoring errors of endocrinopathies. Monitoring errors of the lipid profile and thyroid functions were the most common error types in 94% and 92.6% of the patients treated with novel targeted therapies, respectively. Subsequently, 57% of the monitoring errors in the blood glucose measures were identified. Targeted therapies caused 63 events of endocrinopathies, hyperglycemia in 32% of the patients, thyroid disorders in 15.6% of them and dyslipidemia in 1.5% of the patients. Our study showed a high prevalence of monitoring errors among the cancer patients who received targeted therapies which led to endocrinopathies. It emphasizes the importance of adhering to monitoring strategies and following up on the appropriate referral process.