Comparative effectiveness of five fecal immunochemical tests using colonoscopy as the gold standard: study protocol

Area of Science:

• Oncology
• Gastroenterology
• Public Health

Background:

• Colorectal cancer (CRC) causes nearly 50,000 deaths annually in the US.
• Early detection of CRC significantly improves curability.
• Fecal immunochemical tests (FITs) offer accessible screening for precursor lesions, with many usable at point-of-care (POC).

Purpose of the Study:

• To evaluate the test characteristics of multiple FITs for detecting advanced colorectal neoplasia (ACN).
• To guide the selection of optimal FITs for CRC screening.
• To enhance CRC screening accessibility, particularly in resource-limited settings.

Main Methods:

• Recruitment of 3600 diverse individuals aged 50-85 undergoing colonoscopy.
• Collection of single stool samples for analysis with five different FITs.
• Calculation of test characteristics for each FIT against colonoscopy as the gold standard for ACN detection.

Main Results:

• Complete data available from 2990 participants.
• Participant demographics include 30% Latino and 5.3% Black/African American.
• Full results detailing FIT performance will be presented upon study completion.

Conclusions:

• FITs are crucial for detecting ACN, with colonoscopy as the gold standard.
• Four of the five FITs evaluated are POC tests, offering convenient screening options.
• Wider FIT adoption can increase CRC screening uptake due to ease of use, low cost, and home collection, ultimately reducing the burden of CRC.