Table 2.
Baseline ITSa | Year 3ITSc | ||||
---|---|---|---|---|---|
(N = 198) | (N = 591) | ||||
mt-sDNA | mt-sDNA | ||||
Positive results | Negativeb results | Positive results | Negativeb results | PSId (%) | |
Colonoscopy Finding | (198) | (N/A) | (N = 122) | (N = 469) | 95% CI P |
Colorectal cancer, N (%) | 8 | N/A | 0 | 0 | 0 |
(−3.62, 1.03) | |||||
1 | |||||
Advanced precancerous lesions, N (%) | 61 | 22 (34.9) | 41 (65.1) | 9.3 | |
(1.8,17.6) | |||||
0.0124 | |||||
Negative resultsb: no colorectal cancer, advanced precancerous lesion, or non-advanced lesion, N (%) | 129 | 100 (18.9) | 428 (81.1) | N/A |
aBaseline ITS subjects had both a positive mt-sDNA and an evaluable colonoscopy at baseline.
bNegative subset is defined as Category 3–6.
cYear 3 ITS subjects had a negative baseline mt-sDNA result, a valid year 3 mt-sDNA result, and an evaluable colonoscopy in year 3.
dYear 3 ITS PSI = [PPV3 − (1−NPV3)] = (22/122) − [1−(428/469)] = 18.03% − 8.74 = 9.29% .