Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening (FAMCAP)

February 24, 2026 updated by: Jean Christophe Saurin, Hôpital Edouard Herriot

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.

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
84

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • France
    • Aquitaine
      • Pessac, Aquitaine, France, 33604
        • CHU de Bordeaux - Hôpital Haut-Lévêque
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69000
        • Hôpital Edouard Herriot - Hospices Civils de Lyon
      • Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, France, 42270
        • CHU de Saint-Etienne - Hôpital Nord
    • Bourgogne-Franche-Comté
      • Dijon, Bourgogne-Franche-Comté, France, 21000
        • CHU de Dijon
    • Brittany Region
      • Brest, Brittany Region, France, 29200
        • CHU de Brest - Hopital de la Cavale Blanche
    • Franche-Comté
      • Besançon, Franche-Comté, France, 25030
        • CHU de Besançon - Hôpital Minjoz
    • Limousin
      • Limoges, Limousin, France, 87000
        • CHU de Limoges - Hopital Dupuytren
    • Midi-Pyrénées
      • Toulouse, Midi-Pyrénées, France, 31059
        • CHU de Toulouse
    • Normandy
      • Rouen, Normandy, France, 16000
        • CHU de Rouen - Hôpital Charles Nicolle
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • CHU de Nantes - Hôpital de l'Hôtel-Dieu
    • Provence-Alpes-Côte d'Azur Region
      • Avignon, Provence-Alpes-Côte d'Azur Region, France, 84000
        • CH d'Avignon
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13385
        • Hôpital de la Timone - AP-HM
    • Provence-Alpes-Côte d'Azure
      • Nice, Provence-Alpes-Côte d'Azure, France, 06200
        • CHU de Nice - Hôpital Archet II
    • Île-de-France Region
      • Bobigny, Île-de-France Region, France, 93000
        • Hôpital Avicenne - AP-HP
      • Créteil, Île-de-France Region, France, 94000
        • Chi De Creteil
      • Paris, Île-de-France Region, France, 75012
        • Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris
      • Paris, Île-de-France Region, France, 75014
        • Hôpital Cochin - AP-HP

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
1rst arm: optical colonoscopy (OC)
t0: optical colonoscopy; Follow-up: yearly by phone call for three years
Procedure: optical colonoscopy
optical colonoscopy
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
Procedure: optical colonoscopy
optical colonoscopy
Procedure: colon capsule endoscopy
colon capsule endoscopy
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
Procedure: optical colonoscopy
optical colonoscopy
Diagnostic test: fecal immunological test (FIT)
fecal immunological test (FIT)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Prevalence of advanced colorectal neoplasia or cancer identified by each screening strategy (OC, CC and FIT)
Time Frame: 3 years
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 Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Rate of colorectal cancer identified by each screening strategy
Time Frame: 3 years
The rate of colorectal cancer identified by each strategy (= number of cancer identified by the strategy/number of patients for the strategy) will be calculated at the different steps of the study (t = first exam, t = yearly follow-up and/or interval colonoscopy, t = 3 years upon control colonoscopy) and over the full duration of the study. The rate of initial colorectal cancer, interval colorectal cancer, colorectal cancer at t=3 years and colorectal cancer identified over the duration of the study, respectively, have the same unit, i.e. the number of cancer identified by the strategy/number of patients for the strategy.
3 years

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complication rate
Time Frame: 3 years
Percentage of patient having experienced a significant complication from any screening strategy
3 years
Comparison of the strategies cost
Time Frame: 3 years
Cumulative costs of each strategy compared to the detection of advanced neoplasia/cost per advanced neoplasia detected and cost/life-years gained.
3 years
Quality assessment of colonoscopy and capsule endoscopy
Time Frame: 3 years
Quality assessment of colonoscopy and capsule endoscopy by analysing the rate of completion of colonoscopy and capsule endoscopy, and the caecal intubation rate.
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hôpital Edouard Herriot

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Medtronic
National Cancer Institute, France

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 3, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 2, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 11, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 27, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 24, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • FAMCAP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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