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Comparing colonoscopy, colon capsule, and fecal tests for colorectal cancer screening

Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening, in First Degree Relatives of Patients With Colorectal Neoplasia: a Prospective Randomized Study.

Observational Hôpital Edouard Herriot · NCT02738359

This study is testing which of three different screening methods—colonoscopy, colon capsule, or stool tests—works best for people over 45 with a family history of colorectal cancer.

Quick facts

Study typeObservational
Enrollment3250 (estimated)
Ages45 Years and up
SexAll
SponsorHôpital Edouard Herriot Academic / other
Locations19 sites (Colmar, Alsace and 18 other locations)
Trial IDNCT02738359 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness of three different methods for colorectal cancer screening in individuals with a family history of colorectal neoplasia. It compares optical colonoscopy, colon capsule endoscopy, and fecal immunological tests (FIT) to determine which method is most acceptable and effective for high-risk patients. The study aims to address the limitations of traditional colonoscopy, such as complications and low acceptability, by exploring alternative screening options. Participants will be first-degree relatives of colorectal cancer patients aged 45 and older who have not undergone previous screening.

Who should consider this trial

Good fit: Ideal candidates for this study are individuals aged 45 and older with a family history of colorectal cancer who have not previously undergone screening.

Not a fit: Patients with known advanced neoplasia, colorectal cancer, or genetic predispositions to colorectal cancer may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide safer and more acceptable screening options for individuals at high risk of colorectal cancer.

How similar studies have performed: While there is existing data on the effectiveness of FIT in average-risk populations, this study is novel as it focuses on high-risk individuals and compares it with colon capsule endoscopy.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion criteria:

* History of colorectal cancers (any age) in first-degree relatives (parents, children, siblings including half-brothers and sisters)
* Age \> or = 45 years
* No previous colorectal cancer screening
* Informed patient
* Patient having signed the consent form
* Patient affiliated to a social security system or recipient of such system

Exclusion criteria:

* Any previous colorectal cancer screening:

  * History of blood tests in the stool (hemoccult, fecal immunological test, ...)
  * History of colonic capsule screening
  * History of colonoscopy
* Any known advanced neoplasia or colorectal cancer
* Known genetic predisposition to colorectal cancer (very high risk group)
* Adults protected by law (under guardianship or trusteeship)
* Other metastatic cancers
* Life-threatening diseases

Where this trial is running

Colmar, Alsace and 18 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Colon CancerRectum Cancercolon cancerrectum cancercolonoscopyfecal immunological testcolon capsule
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.