Patient demographics for analysis cohorts.
| Demographic features | All enrolled participants, N = 983 | Intent-to-screen cohorta, N = 842 | Evaluable cohortb,N = 816 |
|---|---|---|---|
| Age (years) | |||
| Mean (SD) | 47.8 (1.5) | 47.9 (1.5) | 47.8 (1.5) |
| Sex, n (%) | |||
| Male | 518 (52.7%) | 440 (52.3%) | 427 (52.3%) |
| Female | 465 (47.3%) | 402 (47.7%) | 389 (47.7%) |
| Race, n (%) | |||
| White | 803 (81.7%) | 706 (83.8%) | 685 (83.9%) |
| Black or African American | 127 (12.9%) | 95 (11.3%) | 90 (11.0%) |
| Asian | 41 (4.2%) | 31 (3.7%) | 31 (3.8%) |
| American Indian or Alaska Native | 1 (0.1%) | 1 (0.1%) | 1 (0.1%) |
| Native Hawaiian or Other Pacific Islander | 1 (0.1%) | 1 (0.1%) | 1 (0.1%) |
| Other | 10 (1.0%) | 8 (1.0%) | 8 (1.0%) |
| Ethnicity, n (%) | |||
| Hispanic or Latino | 67 (6.8%) | 48 (5.7%) | 47 (5.8%) |
| Not Hispanic or Latino | 916 (93.2%) | 794 (4.3%) | 769 (94.2%) |
↵aThe intent-to-screen cohort included participants with a valid or usable mt-sDNA and a reportable or complete colonoscopy.
↵bThe evaluable cohort included only participants with a usable mt-sDNA and complete colonoscopy. Participants with stool samples received outside of the 72-hour mt-sDNA processing window, incomplete/not reportable colonoscopies, and other major protocol violations (inclusion/exclusion criteria not met) were excluded.