CRC-PREVENT
Multitarget Stool RNA Test (ColoSense) for Colorectal Cancer Screening (CRC-PREVENT)
Phase 3N = 8,920NCT04739722
- Population
- Individuals aged 45 years and older recruited online (mean age 55, range 45 to 90); 8,920 eligible participants. Sponsor: Geneoscopy.
- Design
- Blinded, prospective, cross-sectional study, described in the abstract as a phase 3 clinical trial, to support a premarket approval application. Participants aged 45 years and older were identified online through social media and enrolled between June 2021 and June 2022 through a decentralized nurse call center; 8,920 eligible participants in 49 US states had colonoscopy at more than 3,800 endoscopy centers. The multitarget stool RNA test combined a commercially available FIT, 8 RNA transcripts and smoking status; its results were compared with colonoscopy and with the FIT component. Primary outcomes: sensitivity for colorectal cancer and advanced adenomas and specificity for no lesions on colonoscopy. 36 participants (0.40%) had colorectal cancer and 606 (6.8%) advanced adenomas.
- Primary endpoint
- Sensitivity for colorectal cancer, Sensitivity for advanced adenomas, Specificity for negative colonoscopy
- Arms
- Multitarget stool RNA test (experimental, n = 8,920): Stool RNA transcripts plus FIT hemoglobin and smoking status (ColoSense)
- FIT component (control, n = 8,920): Commercially available fecal immunochemical test
- People
- Barnell EK
Δ Sensitivity for colorectal cancer+16.6 pointsΔ Sensitivity for advanced adenomas+17 pointsΔ Specificity for negative colonoscopy−7.8 points
Show the numbers
| Endpoint | Analysis | Multitarget stool RNA test | FIT component | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerParticipants with colorectal cancer (36 of 8,920)Proportion of participants with colorectal cancer on colonoscopy whose test was positive | primaryBarnell 2023 | 94.4% (81–99%) | 77.8% (61–90%) | P=0.01 (McNemar)34 of 36 cancers detected by the stool RNA test and 28 of 36 by the FIT. Stage I: 14 of 14 detected (95% CI 77 to 100), a small number. Paired comparison in the same participants. Confidence intervals as printed to whole percentages. FDA primary cohort figures differ (see milestone facts). |
| Sensitivity for advanced adenomasParticipants with advanced adenomas (606 of 8,920)Proportion of participants with an advanced adenoma on colonoscopy whose test was positive | primaryBarnell 2023 | 45.9% (42–50%) | 28.9% (25–33%) | P<0.001 (McNemar)Paired comparison in the same participants. Confidence intervals as printed to whole percentages. |
| Specificity for negative colonoscopyParticipants with no lesions on colonoscopy (3,760)Proportion of participants with no lesions on colonoscopy whose test was negative | primaryBarnell 2023 | 87.9% (87–89%) | 95.7% (95–96%) | P<0.001Lower for the stool RNA test than for the FIT component: more false-positive results. Confidence intervals as printed to whole percentages. |
| Endpoint | Analysis | Multitarget stool RNA test | FIT component | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerParticipants with colorectal cancer (36 of 8,920)Proportion of participants with colorectal cancer on colonoscopy whose test was positive | primaryBarnell 2023 | 94.4% (81–99%) | 77.8% (61–90%) | P=0.01 (McNemar)34 of 36 cancers detected by the stool RNA test and 28 of 36 by the FIT. Stage I: 14 of 14 detected (95% CI 77 to 100), a small number. Paired comparison in the same participants. Confidence intervals as printed to whole percentages. FDA primary cohort figures differ (see milestone facts). |
| Sensitivity for advanced adenomasParticipants with advanced adenomas (606 of 8,920)Proportion of participants with an advanced adenoma on colonoscopy whose test was positive | primaryBarnell 2023 | 45.9% (42–50%) | 28.9% (25–33%) | P<0.001 (McNemar)Paired comparison in the same participants. Confidence intervals as printed to whole percentages. |
| Specificity for negative colonoscopyParticipants with no lesions on colonoscopy (3,760)Proportion of participants with no lesions on colonoscopy whose test was negative | primaryBarnell 2023 | 87.9% (87–89%) | 95.7% (95–96%) | P<0.001Lower for the stool RNA test than for the FIT component: more false-positive results. Confidence intervals as printed to whole percentages. |