DeeP-C
Multi-Target Colorectal Cancer Screening Test for the Detection of Colorectal Advanced Adenomatous Polyps and Cancer: DeeP-C Study
Phase observationalN = 9,989NCT01397747
- Population
- Asymptomatic persons at average risk for colorectal cancer; 9,989 could be evaluated, of whom 65 (0.7%) had colorectal cancer and 757 (7.6%) had advanced precancerous lesions on colonoscopy. Funded by Exact Sciences.
- Design
- Comparison of a noninvasive multitarget stool DNA test (KRAS mutations, aberrant NDRG4 and BMP3 methylation, beta-actin and a hemoglobin immunoassay, scored by a logistic-regression algorithm with 183 or more positive) with a fecal immunochemical test (FIT, positive above 100 ng hemoglobin per milliliter of buffer) in persons at average risk, each compared with colonoscopy. Tests were processed independently of colonoscopic findings. The FDA summary describes a prospective, cross-sectional, multicenter study at 90 sites in the US and Canada (12,776 enrolled), with colonoscopy within 90 days of enrollment.
- Primary endpoint
- Sensitivity for colorectal cancer, Specificity for advanced neoplasia
- Arms
- Multitarget stool DNA test (experimental, n = 9,989): Stool DNA markers plus hemoglobin immunoassay, positive at an algorithm value of 183 or more
- FIT (control, n = 9,989): Fecal immunochemical test, positive above 100 ng hemoglobin per milliliter of buffer
- People
- Imperiale TF
Δ Sensitivity for colorectal cancer+18.5 pointsΔ Sensitivity for advanced precancerous lesions+18.6 pointsΔ Specificity for advanced neoplasia−8.3 pointsΔ Specificity for negative colonoscopy−6.6 points
Show the numbers
| Endpoint | Analysis | Multitarget stool DNA test | FIT | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerEvaluable participants (9,989); 65 with colorectal cancerProportion of participants with colorectal cancer on colonoscopy whose test was positive | primaryImperiale 2014 | 92.3% | 73.8% | P=0.002Paired comparison in the same participants, not randomized. The abstract prints no confidence interval; the FDA summary gives a two-sided 95% CI of 83.0 to 97.5 for the DNA test in its primary effectiveness population (10,023 participants; 60 of 65 cancers detected), see milestone facts. |
| Sensitivity for advanced precancerous lesionsEvaluable participants (9,989); 757 with advanced precancerous lesionsProportion of participants with an advanced precancerous lesion (advanced adenoma or sessile serrated polyp of 1 cm or more) on colonoscopy whose test was positive | primaryImperiale 2014 | 42.4% | 23.8% | P<0.001Paired comparison in the same participants. No confidence intervals in the abstract. |
| Specificity for advanced neoplasiaEvaluable participants with nonadvanced or negative colonoscopy findingsProportion of participants without colorectal cancer or advanced precancerous lesions on colonoscopy whose test was negative | primaryImperiale 2014 | 86.6% | 94.9% | P<0.001Lower for the DNA test: more false-positive results. The FDA summary gives a two-sided 95% CI of 85.9 to 87.3 for the DNA test in its primary effectiveness population (10,023 participants; 7,967 of 9,198), see milestone facts. |
| Specificity for negative colonoscopyEvaluable participants with a negative colonoscopyProportion of participants with a negative colonoscopy whose test was negative | exploratoryImperiale 2014 | 89.8% | 96.4% | P<0.001No confidence intervals in the abstract. |
| Endpoint | Analysis | Multitarget stool DNA test | FIT | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerEvaluable participants (9,989); 65 with colorectal cancerProportion of participants with colorectal cancer on colonoscopy whose test was positive | primaryImperiale 2014 | 92.3% | 73.8% | P=0.002Paired comparison in the same participants, not randomized. The abstract prints no confidence interval; the FDA summary gives a two-sided 95% CI of 83.0 to 97.5 for the DNA test in its primary effectiveness population (10,023 participants; 60 of 65 cancers detected), see milestone facts. |
| Sensitivity for advanced precancerous lesionsEvaluable participants (9,989); 757 with advanced precancerous lesionsProportion of participants with an advanced precancerous lesion (advanced adenoma or sessile serrated polyp of 1 cm or more) on colonoscopy whose test was positive | primaryImperiale 2014 | 42.4% | 23.8% | P<0.001Paired comparison in the same participants. No confidence intervals in the abstract. |
| Specificity for advanced neoplasiaEvaluable participants with nonadvanced or negative colonoscopy findingsProportion of participants without colorectal cancer or advanced precancerous lesions on colonoscopy whose test was negative | primaryImperiale 2014 | 86.6% | 94.9% | P<0.001Lower for the DNA test: more false-positive results. The FDA summary gives a two-sided 95% CI of 85.9 to 87.3 for the DNA test in its primary effectiveness population (10,023 participants; 7,967 of 9,198), see milestone facts. |
| Specificity for negative colonoscopyEvaluable participants with a negative colonoscopyProportion of participants with a negative colonoscopy whose test was negative | exploratoryImperiale 2014 | 89.8% | 96.4% | P<0.001No confidence intervals in the abstract. |