BLUE-C
The study behind Cologuard Plus: the new stool test caught 94% of bowel cancers and produced fewer false alarms than the original.
Overview
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.
- 93.9 vs 67.3 out of 100 reached this endpoint with Next-generation mt-sDNA (Cologuard Plus) compared with FIT; 26.6 more per 100.
- Roughly one extra person helped for every 4 treated. That is a rough figure taken from the two percentages, not a guarantee for any one person.
- 90.6 vs 94.8 out of 100 reached this endpoint with Next-generation mt-sDNA (Cologuard Plus) compared with FIT; 4.2 fewer per 100.
- On this measure the first group did worse, not better.
- 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 the next-generation multitarget stool DNA test (Cologuard Plus) and FIT against screening colonoscopy in average-risk adults aged 40 and over. 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.
20,176 participants enrolled.
| Endpoint | Arm | n | Value | HR (95% CI) | p | Source |
|---|---|---|---|---|---|---|
| Sensitivity for colorectal cancerprimary | Next-generation mt-sDNA (Cologuard Plus) | — | 93.9% | — | — | link |
| FIT | — | 67.3% | ||||
| Specificity for advanced neoplasiaprimary | Next-generation mt-sDNA (Cologuard Plus) | — | 90.6% | — | — | — |
| FIT | — | 94.8% |
Pages like this
not linked directly; found by shared links- TrialDeeP-C
Shares Sensitivity and specificity, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- TrialNordICC (Nordic-European Initiative on Colorectal Cancer)
Shares Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- ProductCologuard
Shares Cologuard Plus, Faecal immunochemical test (FIT), Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.
- ProductSimpleScreen CRC
Shares Sensitivity and specificity, Cologuard Plus, 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.
- PersonHermann Brenner
Shares Colorectal cancer screening (colonoscopy, FIT, stool DNA, blood), Colorectal cancer.