Randomized Colorectal Cancer Screening Trial Includes Risk-Stratified Arm

Colorectal cancer (CRC) screening can be offered to patients as a menu of screening options; sequential testing (colonoscopy offered first with another testing option offered when colonoscopy is refused); or a risk-stratified approach, in which colonoscopy is offered to high-risk patients and fecal immunochemical testing (FIT) is offered to low-risk patients. Thus far, no randomized controlled trial (RCT) has evaluated the risk-stratified approach. 

In a trial from China, 19,546 persons aged 50 to 74 years were randomized into 3 groups: one-time colonoscopy, annual FIT, or risk-adapted screening. The cutoff for positive FIT was 4 µg Hgb/g feces, resulting in a positive FIT rate of 14%. Risk was assigned based on the Asia-Pacific Colorectal Screening score, which uses age, gender, CRC history in first-degree relatives, smoking, and body mass index. In the risk arm, 18.9% of patients were assessed as high risk.

Overall participation rates in the colonoscopy, FIT, and risk arms were 42.5%, 94%, and 85.2%, respectively. On an intent-to-screen basis, CRC rates were 0.23%, 0.09%, and 0.17%, respectively. Advanced adenoma rates were 2.17%, 1.04%, and 1.49%, respectively. The numbers of colonoscopies to detect one advanced neoplasm were 18, 10, and 11, respectively.