Dataset Information

Evaluation of the Clinical Performance of the ColoSTAT Diagnostic for colorectal cancer biomarkers

ABSTRACT: Interventions: This prospective, cross-sectional, multi-centre, blinded clinical trial evaluates the performance of the ColoSTAT as an in vitro diagnostic test (IVD) for the early detection of colorectal cancer. Participants will be recruited from two cohorts: Chort 1, patients recently diagnosed via colonoscopy with colorectal cancer who are progressing to colorectal surgery or neoadjuvant treatment as part of their normal standard of care; Cohort 2, patients with no prior history of colorectal cancer who have been referred for colonoscopy by their consulting physician. Participants will be asked to donate around 18 mL of blood for use in the ColoSTAT test. Further, if they do not have a valid result from a faecal immunochemical test (FIT) completed within the preceding 6 months, participants will be asked to complete a FIT sample collection using a commercial FIT home collection kit (provided) and return the samples to the study site for shipment to a central laboratory for testing . Physically, participation in the trial will involve collection of the blood sample for the ColoSTAT test, completion of a home FIT sample collection if needed and return of the completed kit to the the study site. Additionally, information that will be collected at that first visit will comprise: Details of smoking status and age (known risk factors for colorectal cancer), any personal and/or family medical history of colorectal cancer, results from a FIT performed within the previous 6 months and a listing of any concomitant medications. Vital signs, including height, weight, waist circumference, body mass index, blood pressure and heart rate will also be collected and reported. This first Visit is expected to take around 1-2 hour to complete. Sometime during the period Day 10 through 28 Primary outcome(s): Assessment of the sensitivity of ColoSTAT for detection of colorectal cancers compared with the gold standard - colonoscopy. This is calculated as the % of true colorectal cancers (as defined by colonoscopy) that are correctly classified by the ColoSTAT test. [One year from commencement of recruitment.];Assessment of the specificity of ColoSTAT for detection of colorectal cancers compared with the gold standard - colonoscopy. This is calculated as the % of true cancer-negative participants (as defined by colonoscopy) that are correctly classified as negative by the ColoSTAT test.[One year after commencement of recruitment] Study Design: Purpose: Diagnosis; Allocation: Non-randomised trial

DISEASE(S): Early Detection Of Colorectal Cancer,Cancer-bowel-back Passage (rectum) Or Large Bowel (colon)

PROVIDER: 2468748 | ecrin-mdr-crc |

REPOSITORIES: ECRIN MDR

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Project description:Colorectal cancer often arises from adenomatous polyps. Polyps can grow and progress to cancer, but may also remain static in size, regress, or resolve. Prediciting which progress to cancer and which remain benign is difficult. We developed a long-lived murine model of colorectal cancer with tumors that can be followed by colonoscopy. Our aim was to assess whether these tumors have similar growth patterns and histologic fates to human colorectal polyps to identify features to aid in risk stratification of colonic tumors. Long-lived Apcin/+ mice were treated with 4% dextran sodium sulfate to promote colonic tumorigenesis. Tumor growth patterns were characterized by serial colonoscopy, and pathology was determined. Serial biopsies of tumors were obtained for immunohistochemistry and gene expression profiling by microarray analysis with Affymetrix Whole Genome array. Tumors (n=424) grew, remained static, regressed, or resolved over time with different relative frequencies. Newly developed tumors demonstrated dynamic growth patterns with higher rates of growth and resolution, while more established tumors tended to remain static in size. Colonic tumors were hyperplastic lesions (3%), adenomas (73%), intramucosal carcinomas (20%), or adenocarcinomas (3%). Differentially expressed genes between adenomas and intramucosal carcinomas were identified. We did not identify differentially expressed genes between early and late biopsies from the same tumor. This novel murine model of intestinal tumorigenesis develops colonic tumors that can be monitored by serial colonoscopy, mirror growth patterns seen in human colorectal polyps, and progress to colorectal cancer. Further characterization of cellular and molecular features are needed to determine which features can be used to risk-stratify polyps for progress to colorectal cancer and potentially guide prevention strategies. F1 (SWR x C57BL/6) Apcin/+ mice who had been given two treatments of 4% dextran sodium sulfate in drinking water at weaning underwent colonoscopy around 80 days of age. Those with distal colonic tumors amenable to biopsy had two biopsies taken at that time. Tumors were monitored by colonoscopy every 14 days. Every 28 days, two additional biopsies were taken of each tumor. This protocol was repeated until mice were moribund. Six tumors were removed after sacrifice. The earliest and latest biopsies of each tumor were selected for RNA extraction and Affymetrix hybridization.

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Evaluation of the Clinical Performance of the ColoSTAT Diagnostic for colorectal cancer biomarkers

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