AzTrials
AzTrials

Colon CancerFAMCAPNCT02738359

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

An observational study of Colon Cancer and Rectum Cancer, run by Hôpital Edouard Herriot at 17 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 45 years and olderHealthy volunteers can take part
Conditions the study is for
Colon Cancer, Rectum Cancer
What is being tested?
optical colonoscopy, colon capsule endoscopy and fecal immunological test (FIT)
How many people
84 participants
Where
17 sitesFrance
Study dates
3 Nov 2017to 2 Jan 2026
How long will I take part?
3 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 45 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

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.

Who may be able to join

  • 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

Who cannot join

  • 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)
Show all 9Show fewer
  • Adults protected by law (under guardianship or trusteeship)
  • Other metastatic cancers
  • Life-threatening diseases

Trial locations and contacts

17 sites in 1 country.

17 sites in 1 country

France17 sites

  • CH d'Avignon

    Avignon, Provence-Alpes-Côte d'Azur Region, 84000

  • CHU de Besançon - Hôpital Minjoz

    Besançon, Franche-Comté, 25030

  • Hôpital Avicenne - AP-HP

    Bobigny, Île-de-France Region, 93000

  • CHU de Brest - Hôpital de la Cavale Blanche

    Brest, Brittany Region, 29200

  • CHI de Créteil

    Créteil, Île-de-France Region, 94000

  • CHU de Dijon

    Dijon, Bourgogne-Franche-Comté, 21000

  • CHU de Limoges - Hôpital Dupuytren

    Limoges, Limousin, 87000

  • Hôpital Edouard Herriot - Hospices civils de Lyon

    Lyon, Auvergne-Rhône-Alpes, 69000

  • Hôpital de la Timone - AP-HM

    Marseille, Provence-Alpes-Côte d'Azur Region, 13385

  • CHU de Nantes - Hôpital de l'Hôtel-Dieu

    Nantes, Pays de la Loire Region, 44000

  • CHU de Nice - Hôpital Archet II

    Nice, Provence-Alpes-Côte d'Azure, 06200

  • Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris

    Paris, Île-de-France Region, 75012

  • Hôpital Cochin - AP-HP

    Paris, Île-de-France Region, 75014

  • CHU de Bordeaux - Hôpital Haut-Lévêque

    Pessac, Aquitaine, 33604

  • CHU de Rouen - Hôpital Charles Nicolle

    Rouen, Normandy, 16000

  • CHU de Saint-Etienne - Hôpital nord

    Saint-Priest-en-Jarez, Auvergne-Rhône-Alpes, 42270

  • CHU de Toulouse

    Toulouse, Midi-Pyrénées, 31059

Other trials in France

About this study

Official title: 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.

Read the 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.

Being tested
optical colonoscopy, colon capsule endoscopy, fecal immunological test (FIT)
Keywords
colon cancer, rectum cancer, colonoscopy, fecal immunological test, colon capsule
Medical subject headings
Colonic Neoplasms, Rectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • optical colonoscopyProcedure or surgery

    optical colonoscopy

  • colon capsule endoscopyProcedure or surgery

    colon capsule endoscopy

  • fecal immunological test (FIT)Diagnostic test

    fecal immunological test (FIT)

Study groups in NCT02738359
Study groupRoleWhat they receive
1rst arm: optical colonoscopy (OC)t0: optical colonoscopy; Follow-up: yearly by phone call for three years
Receives: Procedure: 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
Receives: Procedure: optical colonoscopy; Procedure: 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
Receives: Procedure: optical colonoscopy; Diagnostic Test: fecal immunological test (FIT)

What is being measured

The primary outcome is the main question the study is designed to answer.

  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%.

    Measured: 3 years

Secondary outcomes (1)

  1. Rate of colorectal cancer identified by each screening strategy

    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.

    Measured: 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Apr 2016 (estimated)
  2. Study start3 Nov 2017
  3. Primary completion1 Nov 2021
  4. Study completion2 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
84 participants (actual)
Target duration
3 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02738359
Sponsor's protocol ID
FAMCAP
Acronym
FAMCAP
Status last verified
Feb 2026
First submitted
11 Apr 2016
Last updated
27 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Colon Cancer and Rectum Cancer, run by Hôpital Edouard Herriot at 17 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 17 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prevalence of advanced colorectal neoplasia or cancer identified by each screening strategy (OC, CC and FIT) (time frame: 3 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02738359.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in