Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening
FAMCAP
1 other identifier
observational
84
1 country
17
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Nov 2017
Longer than P75 for all trials
17 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 11, 2016
CompletedFirst Posted
Study publicly available on registry
April 14, 2016
CompletedStudy Start
First participant enrolled
November 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
January 2, 2026
CompletedFebruary 27, 2026
February 1, 2026
4 years
April 11, 2016
February 24, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Prevalence of advanced colorectal neoplasia or cancer identified by each screening strategy (OC, CC and FIT)
The main objective of the study is to compare two alternative methods (CC anf FIT) to OC in term of non-inferiority for the detection of advanced colorectal neoplasia (adenoma \> 1 cm, adenoma with high grade dysplasia) or cancer. The method of the unilateral confidence interval of the difference will be used to test the non-inferiority. The strategies will be considered to be equivalent if the 95% confidence interval of the difference or the detection of advanced neoplasia won't exceed ±3%.
3 years
Secondary Outcomes (1)
Rate of colorectal cancer identified by each screening strategy
3 years
Other Outcomes (3)
Complication rate
3 years
Comparison of the strategies cost
3 years
Quality assessment of colonoscopy and capsule endoscopy
3 years
Study Arms (3)
1rst arm: optical colonoscopy (OC)
t0: optical colonoscopy; Follow-up: yearly by phone call for three years
2nd arm: colon capsule endoscopy (CC)
t0: colon capsule endoscopy -\> if positive: OC; At three years: OC for those patients with negative initial CC; Follow-up: yearly by phone call for 3 years
3rd arm: fecal immunological test (FIT)
FIT yearly for two years: t0: FIT -\> if positive : OC; t = 1 year: FIT -\> if positive : OC; t = 2 years: FIT -\> if positive : OC; At three years: OC for those patients with negative FIT during the study Follow-up: yearly by phone call for 3 years
Interventions
optical colonoscopy
fecal immunological test (FIT)
Eligibility Criteria
Patients at high risk of colorectal cancer (first-degree relatives of patient with colorectal cancer) will be included prospectively in one of the 3 comparative arms.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Medtroniccollaborator
- Hôpital Edouard Herriotlead
- National Cancer Institute, Francecollaborator
Study Sites (17)
CHU de Bordeaux - Hôpital Haut-Lévêque
Pessac, Aquitaine, 33604, France
Hôpital Edouard Herriot - Hospices civils de Lyon
Lyon, Auvergne-Rhône-Alpes, 69000, France
CHU de Saint-Etienne - Hôpital nord
Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270, France
CHU de Dijon
Dijon, Bourgogne-Franche-Comté, 21000, France
CHU de Brest - Hôpital de la Cavale Blanche
Brest, Brittany Region, 29200, France
CHU de Besançon - Hôpital Minjoz
Besançon, Franche-Comté, 25030, France
CHU de Limoges - Hôpital Dupuytren
Limoges, Limousin, 87000, France
CHU de Toulouse
Toulouse, Midi-Pyrénées, 31059, France
CHU de Rouen - Hôpital Charles Nicolle
Rouen, Normandy, 16000, France
CHU de Nantes - Hôpital de l'Hôtel-Dieu
Nantes, Pays de la Loire Region, 44000, France
CH d'Avignon
Avignon, Provence-Alpes-Côte d'Azur Region, 84000, France
Hôpital de la Timone - AP-HM
Marseille, Provence-Alpes-Côte d'Azur Region, 13385, France
CHU de Nice - Hôpital Archet II
Nice, Provence-Alpes-Côte d'Azure, 06200, France
Hôpital Avicenne - AP-HP
Bobigny, Île-de-France Region, 93000, France
CHI de Créteil
Créteil, Île-de-France Region, 94000, France
Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris
Paris, Île-de-France Region, 75012, France
Hôpital Cochin - AP-HP
Paris, Île-de-France Region, 75014, France
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jean-Christophe Saurin, Pr
Hôpital Edouard Herriot - Hospices civils de Lyon
- STUDY CHAIR
Robert Benamouzig, Pr
Hôpital Avicenne - Assistance publique-Hôpitaux de Paris
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 3 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
April 11, 2016
First Posted
April 14, 2016
Study Start
November 3, 2017
Primary Completion
November 1, 2021
Study Completion
January 2, 2026
Last Updated
February 27, 2026
Record last verified: 2026-02