Specificity of the Multi-Target Stool DNA Test for Colorectal Cancer Screening in Average-Risk 45–49 Year-Olds: A Cross-Sectional Study

DOI: 10.1158/1940-6207.CAPR-20-0294 Published April 2021

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Figure 1.
Flowchart for evaluable cohort.
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Figure 2.
ROC curves for mt-sDNA test specificity. A, ROC for the evaluable cohort discriminating between advanced precancerous lesions and lesser findings (nonadvanced adenoma and negative colonoscopy). B, ROC for the evaluable cohort discriminating between advanced precancerous lesions and negative colonoscopy. AUC, area under the receiver operating characteristic; ROC, receiver operating characteristic.

Table 1.

Patient demographics for analysis cohorts.

Demographic features	All enrolled participants, N = 983	Intent-to-screen cohort^a, N = 842	Evaluable cohort^b,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.

Table 2.

Test performance in the evaluable cohort.

			mt-sDNA (N = 816)
Most advanced finding	Colonoscopy (N = 816) no.		Positive Results, no.	Specificity, % (95% CI)
All nonadvanced adenomas, non-neoplastic findings, and negative results on colonoscopy	767		37	95.2 (93.4–96.6)
Negative results on colonoscopy	514		19	96.3 (94.3–97.8)
		Prevalence, % (N = 816)		Sensitivity, % (95% CI)
Colorectal cancer	0	NA	NA	NA
Advanced precancerous lesions^a	49	6.0	16	32.7 (19.9–47.5)
High-grade dysplasia	0	<0.1	NA	NA
Adenoma, villous growth pattern	10	1.2	6	60.0 (26.2–87.8)
Adenoma ≥10 mm	32	3.9	7	28.1 (13.7–46.7)
Serrated lesion ≥10 mm	7	0.9	1	14.3 (0.4–57.9)
Nonadvanced adenoma	253	31.0	18	7.1 (4.3–11.0)

Abbreviations: NA, not applicable; no., number.
↵^aOn the basis of most advanced lesion; therefore, prevalence estimates for less advanced lesions are biased downward.