DeeP-C
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.
Overview
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.
- 92.3 vs 73.8 out of 100 reached this endpoint with Multitarget stool DNA (Cologuard) compared with FIT; 18.5 more per 100.
- Roughly one extra person helped for every 5 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- This endpoint is not one of the standard survival or response measures; read it alongside the trial's primary result.
- These results apply to the people the trial enrolled: Prospective cross-sectional study of multitarget stool DNA (Cologuard) and FIT against screening colonoscopy in average-risk adults aged 50 to 84. People in a different situation may not see the same effect.
Numbers are from the trial as recorded here; see the source links in the table below. This is orientation, not medical advice: ask your team how closely the trial population matches you.
Pages like this
not linked directly; found by shared links- TrialBLUE-C
Shares Sensitivity and specificity, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- ProductCologuard Plus
Shares Sensitivity and specificity, Cologuard, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood).
- TrialNordICC (Nordic-European Initiative on Colorectal Cancer)
Shares Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- TrialECLIPSE (Shield blood test)
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- Key paperMinnesota trial: a yearly stool blood test cuts bowel cancer deaths by a third
Shares Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- PersonDame Deborah James
Shares Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- ProductSimpleScreen CRC
Shares Sensitivity and specificity, Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- PersonHermann Brenner
Shares Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.