{"entity":{"id":"blue-c","kind":"trial","name":"BLUE-C","aka":[],"tldr":"The study behind Cologuard Plus: the new stool test caught 94% of bowel cancers and produced fewer false alarms than the original.","summary":"Among 20,176 participants with colonoscopy as the reference (NEJM 2024), sensitivity for colorectal cancer was 93.9% for the next-generation test versus 67.3% for FIT, sensitivity for advanced precancerous lesions 43.4% versus 23.3%, and specificity for advanced neoplasia 90.6% versus 94.8%. Specificity was higher than in the original DeeP-C study, which translates into fewer unnecessary colonoscopies per cancer found.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT04144738","url":"https://clinicaltrials.gov/study/NCT04144738"},{"label":"BLUE-C (NEJM 2024)","url":"https://doi.org/10.1056/NEJMoa2310336"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","methylation-profiling"],"targets":[],"drugs":["cologuard-plus"],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["fit-test","sensitivity-specificity"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-blue-c-n-engl-j-med-2024"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT04144738","phase":"observational","setting":"Prospective cross-sectional study of the next-generation multitarget stool DNA test (Cologuard Plus) and FIT against screening colonoscopy in average-risk adults aged 40 and over","sponsor":"Exact Sciences","result":"Sensitivity 93.9% for colorectal cancer (FIT 67.3%); specificity 90.6% for advanced neoplasia.","started":"2019-11-15","startedType":"actual","yearReported":2024,"enrolled":20176,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for colorectal cancer","primary":true,"unit":"%","arms":[{"name":"Next-generation mt-sDNA (Cologuard Plus)","value":93.9},{"name":"FIT","value":67.3}],"source":"https://doi.org/10.1056/NEJMoa2310336"},{"endpoint":"Specificity for advanced neoplasia","primary":true,"unit":"%","arms":[{"name":"Next-generation mt-sDNA (Cologuard Plus)","value":90.6},{"name":"FIT","value":94.8}],"source":"https://doi.org/10.1056/NEJMoa2310336"}]},"route":"/trials/blue-c/","neighbours":{"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"technology":[{"id":"colorectal-screening","kind":"technology","name":"Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)","route":"/technologies/colorectal-screening/"},{"id":"methylation-profiling","kind":"technology","name":"DNA methylation profiling","route":"/technologies/methylation-profiling/"}],"drug":[{"id":"cologuard-plus","kind":"drug","name":"Cologuard Plus","route":"/drugs/cologuard-plus/"}],"company":[{"id":"exact-sciences","kind":"company","name":"Exact Sciences (Abbott)","route":"/companies/exact-sciences/"}],"term":[{"id":"fit-test","kind":"term","name":"Faecal immunochemical test (FIT)","route":"/terms/fit-test/"},{"id":"sensitivity-specificity","kind":"term","name":"Sensitivity and specificity","route":"/terms/sensitivity-specificity/"}],"paper":[{"id":"paper-blue-c-n-engl-j-med-2024","kind":"paper","name":"Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening","route":"/key-papers/paper-blue-c-n-engl-j-med-2024/"}]}}