# DeeP-C

Source: https://onco.cc/trials/deep-c/  
OnCo record `deep-c` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Registry id: 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
- Enrolled: 9989
- Result: Sensitivity 92.3% for colorectal cancer (FIT 73.8%); specificity 86.6% (FIT 94.9%).
- Outcomes: Sensitivity for colorectal cancer: Multitarget stool DNA (Cologuard) 92.3% vs FIT 73.8%

## Sources

- ClinicalTrials.gov NCT01397747: https://clinicaltrials.gov/study/NCT01397747
- DeeP-C (NEJM 2014): https://doi.org/10.1056/NEJMoa1311194

## Connected records

- cancers: [Colorectal cancer](https://onco.cc/cancers/colorectal/)
- technologies: [Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood)](https://onco.cc/technologies/colorectal-screening/), [DNA methylation profiling](https://onco.cc/technologies/methylation-profiling/)
- drugs: [Cologuard](https://onco.cc/drugs/cologuard/)
- companies: [Exact Sciences (Abbott)](https://onco.cc/companies/exact-sciences/)
- terms: [Faecal immunochemical test (FIT)](https://onco.cc/terms/fit-test/), [Sensitivity and specificity](https://onco.cc/terms/sensitivity-specificity/)
- key papers: [Multitarget stool DNA testing for colorectal-cancer screening](https://onco.cc/key-papers/paper-imperiale-multitarget-stool-dna-screening-nejm-2014/)

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