Efficacy of Colonoscopy Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening

  • STATUS
    Recruiting
  • participants needed
    3250
  • sponsor
    Hôpital Edouard Herriot
Updated on 8 November 2020
Investigator
Jérémie Jacques, MD
Primary Contact
CHU de Limoges - H pital Dupuytren (1.2 mi away) Contact
+12 other location
endoscopy
colorectal cancer screening
cancer screening

Summary

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.

Description

Fecal immunological test (FIT) is the reference screening method in average risk patient. FIT is proposed every 2 years to all asymptomatic subjects with average risk aged from 50 to 74 years in France. Optical colonoscopy (OC) is the gold standard examination for patients at increased risk of colorectal cancer, like those with a first degree relative with colorectal cancer (relative risk between 2 and 4 times that of the general population). Colonoscopy should be performed in this high risk group before 50 years or 5 to 10 years before the earliest case of colorectal cancer. Optical colonoscopy has important limitations: complications (perforation, bleeding), need to use general anesthesia (in France 95% of colonoscopy are performed under general anesthesia), and low acceptability for screening even in high risk persons (40% in the best cases). In this high risk population, there is a potentially important place for alternative methods. FIT could be one of them, with already a significant amount of data suggesting its interest. No data are available in high risk French patients. Colon capsule endoscopy (CC) is a more recent technique with sparse data in this high risk group, and no prospective comparison with optical colonoscopy in this indication. Capsule endoscopy has the advantage of high feasibility, very low risk, probably (but to be demonstrated) increased acceptability, and represents the closest examination as compared to colonoscopy. This justifies a prospective study comparing in a randomized methodology these 3 modalities for the identification of advanced neoplastic lesions of the colon in well characterized group of subjects at high risk of colorectal cancer. The investigators propose a prospective, randomized protocol of non-inferiority in order to compare the two new strategies to the reference strategy for the detection of advanced colorectal neoplasia (colon or rectal cancers, large adenoma > 1 cm or high grade dysplasia ; 1st arm: OC first; 2nd arm: CC first, OC at 3 years for those patients with negative initial CC; 3rd arm: annual FIT for 2 years (t0, t = 1 year, t = 2 years), colonoscopy at 3 years for those patients with negative FIT during the study). The new strategies will be considered non-inferior to the reference strategy if the study allows to conclude that the absolute reduction of the proportion of detected patients is not greater than 3% in comparison to the reference strategy.

Details
Treatment COLON Capsule endoscopy, optical colonoscopy, fecal immunological test (FIT)
Clinical Study IdentifierNCT02738359
SponsorHôpital Edouard Herriot
Last Modified on8 November 2020

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Eligibility

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Inclusion Criteria

Is your age greater than or equal to 45 yrs?
Gender: Male or Female
Do you have any of these conditions: Malignant neoplasm of colon or Rectal Cancer?
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
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