Influence
September 3, 2025

The Comparative Trials of Fecal Immunochemical Testing vs Colonoscopy: What COLONPREV Tells Us and What to Anticipate From the Others

Thomas Imperiale

Published in the Clinical Gastroenterology and Hepatology. Here is a link to the article.

Regenstrief Institute authors: Thomas F. Imperiale, M.D.

Colorectal cancer (CRC) screening in the U.S. began in 1996 with recommendations for guaiac-based fecal occult blood testing (gFOBT) and sigmoidoscopy, later expanding to colonoscopy and fecal immunochemical testing (FIT) due to greater sensitivity and specificity. Annual or biennial FIT, sigmoidoscopy every 5–10 years, and colonoscopy every 10 years are now guideline-recommended strategies. Until recently, no trial directly compared colonoscopy and FIT for long-term outcomes.

The COLONPREV trial from Spain addressed this gap, randomizing over 57,000 average-risk adults aged 50–69 to either one-time colonoscopy or biennial FIT, measuring 10-year CRC mortality, CRC incidence, and all-cause mortality. Intention-to-screen analyses, reflecting real-world effectiveness, showed no significant differences between FIT and colonoscopy due to modest uptake (39.9% vs 31.8%). “As screened” analyses indicated reductions in CRC mortality and all-cause mortality for both tests, with colonoscopy lowering CRC incidence more, reflecting its preventive role through polyp removal. Per-protocol analyses, reflecting efficacy among those who received the intervention, favored colonoscopy for both CRC incidence and mortality.

COLONPREV provides the first comparative data on programmatic FIT versus colonoscopy, highlighting the importance of uptake, adherence, and test characteristics. Ongoing trials (CONFIRM and SCREESCO) will further clarify the relative effectiveness and efficiency of these screening strategies, informing individual and population-level CRC screening decisions.

Author: 

Thomas F. Imperiale
Affiliations: 
Division of Gastroenterology and Hepatology, Department of Medicine, Indiana University School of Medicine, Indianapolis, Indiana
Center for Health Information and Communication, Health Services Research and Development, Richard L. Roudebush VA Medical Center, Indianapolis, Indiana
The Regenstrief Institute, Inc, Indianapolis, Indiana
The Melvin and Bren Simon Comprehensive Cancer Center, Indianapolis, Indiana

Related News

Arthur Owora, PhD

Machine learning tool improves pediatricians’ ability to identify children at risk for persistent asthma 

Pilot randomized trial finds EHR-integrated decision support improved clinicians’ prediction of school-age asthma  A machine learning tool that analyzes

Health First Indiana generated estimated $742.6 million in savings through key public health services

An analysis from the Regenstrief Institute found that Health First Indiana (HFI), the state’s landmark public health funding initiative,

Office of Strategic Innovation helps connect startups with research expertise

Moving healthcare innovations from promising ideas to real-world impact requires collaboration between researchers, entrepreneurs, healthcare organizations and industry partners.

e-star logo

First E-STAR annual report offers unprecedented view of early access to kidney transplantation

National registry data reveal opportunities to improve referral, evaluation and waitlisting for patients with kidney failure Chronic kidney disease