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

Randall Grout, MD

Widespread diaper need poses serious health threats to families

Shortages impact 41 percent of infants, underscoring need for urgent action Diapers are a basic hygiene necessity for infants

Kathleen Unroe, M.D., M.S., headshot.

Regenstrief research scientist earns celebrated professorship for aging research

The following information was originally posted on the Indiana University School of Medicine website. A distinguished long-term care and

Shaun Grannis, M.D., M.S.

Effectiveness of 2023–2024 COVID-19 vaccines in children in the U.S.

Published in Pediatrics. Here is a link to the article. Regenstrief Institute author: Shaun Grannis, M.D., M.S., Brian Dixon,

Chris Harle, PhD

Supporting electronic health record data usage in research for teams with varying data science and clinical knowledge: a food service analogy approach

Published in the Journal of the American Medical Informatics Association: JAMIA. Here is a link to the article. Regenstrief