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

NCT ID: NCT02738359

Last Updated: 2024-02-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

3250 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-11-03

Study Completion Date

2024-11-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Colon Cancer Rectum Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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1rst arm: optical colonoscopy (OC)

t0: optical colonoscopy; Follow-up: yearly by phone call for three years

optical colonoscopy

Intervention Type 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

optical colonoscopy

Intervention Type PROCEDURE

optical colonoscopy

colon capsule endoscopy

Intervention Type 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

optical colonoscopy

Intervention Type PROCEDURE

optical colonoscopy

fecal immunological test (FIT)

Intervention Type DIAGNOSTIC_TEST

fecal immunological test (FIT)

Interventions

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optical colonoscopy

optical colonoscopy

Intervention Type PROCEDURE

colon capsule endoscopy

colon capsule endoscopy

Intervention Type PROCEDURE

fecal immunological test (FIT)

fecal immunological test (FIT)

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Cancer Institute, France

OTHER_GOV

Sponsor Role collaborator

Medtronic

INDUSTRY

Sponsor Role collaborator

Hôpital Edouard Herriot

OTHER

Sponsor Role lead

Responsible Party

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Jean Christophe Saurin

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jean-Christophe Saurin, Pr

Role: PRINCIPAL_INVESTIGATOR

Hôpital Edouard Herriot - Hospices civils de Lyon

Robert Benamouzig, Pr

Role: STUDY_CHAIR

Hôpital Avicenne - Assistance publique-Hôpitaux de Paris

Locations

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CH Colmar

Colmar, Alsace, France

Site Status WITHDRAWN

CHU de Bordeaux - Hôpital Haut-Lévêque

Pessac, Aquitaine, France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Edouard Herriot - Hospices civils de Lyon

Lyon, Auvergne-Rhône-Alpes, France

Site Status RECRUITING

CHU de Saint-Etienne - Hôpital nord

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

Site Status RECRUITING

CHU de Dijon

Dijon, Bourgogne-Franche-Comté, France

Site Status NOT_YET_RECRUITING

CHU de Brest - Hôpital de la Cavale Blanche

Brest, Brittany Region, France

Site Status ACTIVE_NOT_RECRUITING

CHU de Rennes - Hôpital Pontchaillou

Rennes, Brittany Region, France

Site Status WITHDRAWN

CHU de Besançon - Hôpital Minjoz

Besançon, Franche-Comté, France

Site Status NOT_YET_RECRUITING

CHU de Limoges - Hôpital Dupuytren

Limoges, Limousin, France

Site Status NOT_YET_RECRUITING

CHU de Toulouse

Toulouse, Midi-Pyrénées, France

Site Status NOT_YET_RECRUITING

CHU de Rouen - Hôpital Charles Nicolle

Rouen, Normandy, France

Site Status NOT_YET_RECRUITING

CHU de Nantes - Hôpital de l'Hôtel-Dieu

Nantes, Pays de la Loire Region, France

Site Status ACTIVE_NOT_RECRUITING

CH d'Avignon

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

Site Status RECRUITING

Hôpital de la Timone - AP-HM

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

Site Status NOT_YET_RECRUITING

CHU de Nice - Hôpital Archet II

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

Site Status NOT_YET_RECRUITING

Hôpital Avicenne - AP-HP

Bobigny, Île-de-France Region, France

Site Status ACTIVE_NOT_RECRUITING

CHI de Créteil

Créteil, Île-de-France Region, France

Site Status ACTIVE_NOT_RECRUITING

Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris

Paris, Île-de-France Region, France

Site Status RECRUITING

Hôpital Cochin - AP-HP

Paris, Île-de-France Region, France

Site Status NOT_YET_RECRUITING

Countries

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France

Central Contacts

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Jean-Christophe Saurin, Pr

Role: CONTACT

[email protected]
+33 (0)4 72 11 75 72

olivier vinet, PhD

Role: CONTACT

[email protected]
0472110370

Facility Contacts

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Jean-Christophe Saurin, Pr

Role: primary

[email protected]
+33 (0)4 72 11 75 72

Olivier Vinet, PhD

Role: backup

[email protected]

Emilie Del Tedesco, MD

Role: primary

[email protected]
+33 (0)4 77 82 90 78

Dupin Mélanie

Role: backup

[email protected]
+33 (0)4 77 82 88 75

Sylvain Manfredi, MD

Role: primary

[email protected]
+33 (0)3 80 39 34 07

Nora Perrot, IRC

Role: backup

[email protected]
+33 (0)3 80 28 12 66

Stéphane Koch, MD

Role: primary

[email protected]

Jérémie Jacques, MD

Role: primary

[email protected]
+33 (0)5 55 05 87 72

Karl Barange, MD

Role: primary

[email protected]
+33 (0)5 61 77 25 27

Stéphane Lecleire, MD

Role: primary

[email protected]
+33 (0)2 32 88 85 58

Slim Bramli, MD

Role: primary

[email protected]
+33 (0)4 32 75 33 91

Marilyne Grinand

Role: backup

[email protected]
+33 (0)4 32 75 93 92

Philippe Grandval, MD

Role: primary

[email protected]
+33 (0)4 91 38 60 23

Geoffroy Vanbiervliet, MD

Role: primary

[email protected]
+33 (0)4 92 03 60 18

Céline Baud

Role: backup

[email protected]
+33 (0)4 92 03 59 72

Xavier Dray, Pr

Role: primary

[email protected]
+33 (0)1 49 28 21 60

Fouzia Djenadi

Role: backup

[email protected]
+33 (0)1 49 28 22 02

Stanislas Chaussade, Pr

Role: primary

Provided Documents

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Document Type: Study Protocol

View Document

Other Identifiers

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FAMCAP

Identifier Type: -

Identifier Source: org_study_id

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