# BLUE-C

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

## TL;DR

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.

## Fields

- Kind: Trial
- Status: positive
- Last checked: 2026-09-10
- Registry id: 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
- Enrolled: 20176
- Result: Sensitivity 93.9% for colorectal cancer (FIT 67.3%); specificity 90.6% for advanced neoplasia.
- Outcomes: Sensitivity for colorectal cancer: Next-generation mt-sDNA (Cologuard Plus) 93.9% vs FIT 67.3%; Specificity for advanced neoplasia: Next-generation mt-sDNA (Cologuard Plus) 90.6% vs FIT 94.8%

## Sources

- ClinicalTrials.gov NCT04144738: https://clinicaltrials.gov/study/NCT04144738
- BLUE-C (NEJM 2024): https://doi.org/10.1056/NEJMoa2310336

## 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 Plus](https://onco.cc/drugs/cologuard-plus/)
- 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: [Next-Generation Multitarget Stool DNA Test for Colorectal Cancer Screening](https://onco.cc/key-papers/paper-blue-c-n-engl-j-med-2024/)

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