PREEMPT CRC
Prevention of Colorectal Cancer Through Multiomics Blood Testing (PREEMPT CRC)
Phase observationalN = 27,010NCT04369053
- Population
- Asymptomatic adults aged 45 to 85 at average risk of colorectal cancer, willing to have a screening colonoscopy; evaluable cohort of 27,010 (median age 57.0 years, 55.8% women).
- Design
- Prospective, multicenter, cross-sectional observational study of an investigational blood-based circulating tumor DNA test, with screening colonoscopy and histopathology as the reference. Asymptomatic adults aged 45 to 85 at average risk were enrolled between May 2020 and April 2022 at 201 centers across 49 US states and the United Arab Emirates. Participants, staff and pathologists were blinded to blood test results and laboratory testing was blinded to colonoscopy findings. Evaluable cohort 27,010.
- Primary endpoint
- Sensitivity for colorectal cancer, Specificity for advanced neoplasia, Negative predictive value for advanced neoplasia, Positive predictive value for advanced neoplasia
- Arms
- ctDNA blood-based test (experimental, n = 27,010): Blood draw tested for circulating tumor DNA signals; each result compared with screening colonoscopy and histopathology
- People
- Shaukat A
Show the numbers
| Endpoint | Analysis | ctDNA blood-based test | Control | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerEvaluable cohort (27,010 participants)Proportion of participants with colorectal cancer on colonoscopy whose blood test was positive | primaryShaukat 2025 | 79.2% (68.4–86.9%) | — | 57 of 72 cancers detected. Diagnostic accuracy against colonoscopy; not an incidence or mortality outcome. |
| Specificity for advanced neoplasiaEvaluable cohort (27,010 participants)Proportion of participants without colorectal cancer or advanced precancerous lesions on colonoscopy whose blood test was negative | primaryShaukat 2025 | 91.5% (91.2–91.9%) | — | 22,306 of 24,371 participants without advanced neoplasia had a negative test. |
| Negative predictive value for advanced neoplasiaEvaluable cohort (27,010 participants)Proportion of participants with a negative blood test who had neither colorectal cancer nor an advanced precancerous lesion on colonoscopy | primaryShaukat 2025 | 90.8% (90.7–90.9%) | — | 22,306 of 24,567 negative results. Depends on the prevalence of advanced neoplasia in this cohort. |
| Positive predictive value for advanced neoplasiaEvaluable cohort (27,010 participants)Proportion of participants with a positive blood test who had colorectal cancer or an advanced precancerous lesion on colonoscopy | primaryShaukat 2025 | 15.5% (14.2–16.8%) | — | 378 of 2,443 positive results. Depends on the prevalence of advanced neoplasia in this cohort. |
| Sensitivity for advanced precancerous lesionsEvaluable cohort (27,010 participants)Proportion of participants with an advanced precancerous lesion on colonoscopy whose blood test was positive | primaryShaukat 2025 | 12.5% (11.3–13.8%) | — | 321 of 2,567 lesions detected. The abstract states this did not meet the prespecified acceptance criterion. |
| Endpoint | Analysis | ctDNA blood-based test | Control | Effect |
|---|---|---|---|---|
| Sensitivity for colorectal cancerEvaluable cohort (27,010 participants)Proportion of participants with colorectal cancer on colonoscopy whose blood test was positive | primaryShaukat 2025 | 79.2% (68.4–86.9%) | — | 57 of 72 cancers detected. Diagnostic accuracy against colonoscopy; not an incidence or mortality outcome. |
| Specificity for advanced neoplasiaEvaluable cohort (27,010 participants)Proportion of participants without colorectal cancer or advanced precancerous lesions on colonoscopy whose blood test was negative | primaryShaukat 2025 | 91.5% (91.2–91.9%) | — | 22,306 of 24,371 participants without advanced neoplasia had a negative test. |
| Negative predictive value for advanced neoplasiaEvaluable cohort (27,010 participants)Proportion of participants with a negative blood test who had neither colorectal cancer nor an advanced precancerous lesion on colonoscopy | primaryShaukat 2025 | 90.8% (90.7–90.9%) | — | 22,306 of 24,567 negative results. Depends on the prevalence of advanced neoplasia in this cohort. |
| Positive predictive value for advanced neoplasiaEvaluable cohort (27,010 participants)Proportion of participants with a positive blood test who had colorectal cancer or an advanced precancerous lesion on colonoscopy | primaryShaukat 2025 | 15.5% (14.2–16.8%) | — | 378 of 2,443 positive results. Depends on the prevalence of advanced neoplasia in this cohort. |
| Sensitivity for advanced precancerous lesionsEvaluable cohort (27,010 participants)Proportion of participants with an advanced precancerous lesion on colonoscopy whose blood test was positive | primaryShaukat 2025 | 12.5% (11.3–13.8%) | — | 321 of 2,567 lesions detected. The abstract states this did not meet the prespecified acceptance criterion. |