Figure 1.

Flow chart showing patient recruitment. In total, 1,530 patients were prospectively enrolled into the study. Of the 1,530 enrolled participants, 134 were withdrawn from the study because of lack of eligibility (see Supplementary Methods, Supplementary Digital Content 1, http://links.lww.com/CTG/A618). An additional 24 participants completed the study but were considered ineligible because of failed study logistics (e.g., collection kit was lost in the mail, collection kit was used improperly). Of the 1,372 participants assessed with the RNA-FIT assay, 67 failed RNA quantification (4.9%). No participants failed FIT assessment. The study was performed chronologically, such that the training set comprised the first 939 participants to complete all requirements, and the hold out testing set comprised all remaining participants. An additional retrospective cohort of 22 samples were collected from patients with known disease status (CRC or advanced adenoma) before surgical resection or treatment. AA, advanced adenomas; CRC, colorectal cancer.