{"entity":{"id":"deep-c","kind":"trial","name":"DeeP-C","aka":[],"tldr":"The pivotal study for the first stool DNA test, showing it found more cancers than the standard stool blood test at the cost of more false positives.","summary":"In 9,989 evaluable participants (NEJM 2014), sensitivity for colorectal cancer was 92.3% for the multitarget stool DNA test versus 73.8% for FIT, sensitivity for advanced precancerous lesions 42.4% versus 23.8%, and specificity 86.6% versus 94.9% among participants with non-advanced or negative findings. The FDA approved Cologuard on the basis of these data in August 2014 and Medicare covered it the same day, the first parallel FDA-CMS review.","status":"positive","asOf":"2026-09-10","links":[{"label":"ClinicalTrials.gov NCT01397747","url":"https://clinicaltrials.gov/study/NCT01397747"},{"label":"DeeP-C (NEJM 2014)","url":"https://doi.org/10.1056/NEJMoa1311194"}],"tags":[],"related":[],"cancers":["colorectal"],"sections":[],"technologies":["colorectal-screening","methylation-profiling"],"targets":[],"drugs":["cologuard"],"companies":["exact-sciences"],"institutions":[],"pathways":[],"terms":["fit-test","sensitivity-specificity"],"trials":[],"people":[],"bottlenecks":[],"keyPapers":["paper-imperiale-multitarget-stool-dna-screening-nejm-2014"],"journals":[],"dependsOn":[],"notes":[],"nct":"NCT01397747","phase":"observational","setting":"Prospective cross-sectional study of multitarget stool DNA (Cologuard) and FIT against screening colonoscopy in average-risk adults aged 50 to 84","sponsor":"Exact Sciences","result":"Sensitivity 92.3% for colorectal cancer (FIT 73.8%); specificity 86.6% (FIT 94.9%).","started":"2011-06","yearReported":2014,"enrolled":9989,"enrolledBasis":"registry","outcomes":[{"endpoint":"Sensitivity for colorectal cancer","primary":true,"unit":"%","arms":[{"name":"Multitarget stool DNA (Cologuard)","value":92.3},{"name":"FIT","value":73.8}],"source":"https://doi.org/10.1056/NEJMoa1311194"}]},"route":"/trials/deep-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","kind":"drug","name":"Cologuard","route":"/drugs/cologuard/"}],"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-imperiale-multitarget-stool-dna-screening-nejm-2014","kind":"paper","name":"Multitarget stool DNA testing for colorectal-cancer screening","route":"/key-papers/paper-imperiale-multitarget-stool-dna-screening-nejm-2014/"}]}}