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

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: Recruiting
• Conditions: Colon Cancer; Rectum Cancer
• Intervention / Treatment: Procedure: optical colonoscopy; Procedure: colon capsule endoscopy; Diagnostic test: fecal immunological test (FIT)

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: Observational
• Enrollment (Estimated): 3250

Contacts and Locations

• Study Contact: Name: Jean-Christophe Saurin, Pr; Phone Number: +33 (0)4 72 11 75 72; Email: jean-christophe.saurin@chu-lyon.fr
• Study Contact Backup: Name: olivier vinet, PhD; Phone Number: 0472110370; Email: olivier.vinet@chu-lyon.fr

Study Locations

• France
  • Alsace
    • Colmar, Alsace, France, 68000
      • Withdrawn
      • CH Colmar
  • Aquitaine
    • Pessac, Aquitaine, France, 33604
      • Active, not recruiting
      • CHU de Bordeaux - Hôpital Haut-Lévèque
  • Bourgogne
    • Dijon, Bourgogne, France, 21000
      • Not yet recruiting
      • CHU de Dijon
      • Contact: Sylvain Manfredi, MD; Phone Number: +33 (0)3 80 39 34 07; Email: sylvain.manfredi@chu-dijon.fr
      • Contact: Nora Perrot, IRC; Phone Number: +33 (0)3 80 28 12 66; Email: nora.perrot@chu-dijon.fr
      • Principal Investigator: Sylvain Manfredi, MD
      • Sub-Investigator: Côme Lepage, Pr
  • Bretagne
    • Brest, Bretagne, France, 29200
      • Active, not recruiting
      • CHU de Brest - Hôpital de la Cavale Blanche
    • Rennes, Bretagne, France, 35000
      • Withdrawn
      • CHU de Rennes - Hôpital Pontchaillou
  • Franche-Comté
    • Besançon, Franche-Comté, France, 25030
      • Not yet recruiting
      • CHU de Besançon - Hôpital Minjoz
      • Contact: Stéphane Koch, MD; Email: skoch@chu-besancon.fr
      • Principal Investigator: Stéphane Koch, MD
  • Ile-de-France
    • Bobigny, Ile-de-France, France, 93000
      • Active, not recruiting
      • Hôpital Avicenne - AP-HP
    • Créteil, Ile-de-France, France, 94000
      • Active, not recruiting
      • CHI de Créteil
    • Paris, Ile-de-France, France, 75012
      • Recruiting
      • Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris
      • Contact: Xavier Dray, Pr; Phone Number: +33 (0)1 49 28 21 60; Email: xavier.dray@lrb.aphp.fr
      • Contact: Fouzia Djenadi; Phone Number: +33 (0)1 49 28 22 02; Email: endoscopiesat.urcest@aphp.fr
      • Principal Investigator: Xavier Dray, Pr
    • Paris, Ile-de-France, France, 75014
      • Not yet recruiting
      • Hôpital Cochin - AP-HP
      • Contact: Stanislas Chaussade, Pr
      • Principal Investigator: Stanislas Chaussade, Pr
  • Limousin
    • Limoges, Limousin, France, 87000
      • Not yet recruiting
      • CHU de Limoges - Hopital Dupuytren
      • Contact: Jérémie Jacques, MD; Phone Number: +33 (0)5 55 05 87 72; Email: jeremiejacques@gmail.com
      • Principal Investigator: Jérémie Jacques, MD
      • Sub-Investigator: Denis Sauterau, Pr
      • Sub-Investigator: Anne Le Sidaner, MD
      • Sub-Investigator: Romain Legros, MD
  • Midi-Pyrénées
    • Toulouse, Midi-Pyrénées, France, 31059
      • Not yet recruiting
      • CHU de Toulouse
      • Contact: Karl Barange, MD; Phone Number: +33 (0)5 61 77 25 27; Email: barange.k@chu-toulouse.fr
      • Principal Investigator: Karl Barange, MD
  • Normandie
    • Rouen, Normandie, France, 16000
      • Not yet recruiting
      • CHU de Rouen - Hopital Charles Nicolle
      • Contact: Stéphane Lecleire, MD; Phone Number: +33 (0)2 32 88 85 58; Email: stephane.lecleire@chu-rouen.fr
      • Principal Investigator: Stéphane Lecleire, MD
  • Pays De La Loire
    • Nantes, Pays De La Loire, France, 44000
      • Active, not recruiting
      • CHU de Nantes - Hôpital de l'Hôtel-Dieu
  • Provence-Alpes-Côte d'Azur
    • Avignon, Provence-Alpes-Côte d'Azur, France, 84000
      • Recruiting
      • CH d'Avignon
      • Contact: Slim Bramli, MD; Phone Number: +33 (0)4 32 75 33 91; Email: sbramli@ch-avignon.fr
      • Contact: Marilyne Grinand; Phone Number: +33 (0)4 32 75 93 92; Email: GRINAND.Marilyne@ch-avignon.fr
      • Principal Investigator: Jean-Pierre Arpurt, MD
      • Sub-Investigator: Slim Bramly, MD
      • Sub-Investigator: Serge Bellon, MD
      • Sub-Investigator: Alban Benezech, MD
    • Marseille, Provence-Alpes-Côte d'Azur, France, 13385
      • Not yet recruiting
      • Hôpital de la Timone - AP-HM
      • Contact: Philippe Grandval, MD; Phone Number: +33 (0)4 91 38 60 23; Email: philippe.grandval@ap-hm.fr
      • Principal Investigator: Philippe Grandval, MD
  • Provence-Alpes-Côte d'Azure
    • Nice, Provence-Alpes-Côte d'Azure, France, 06200
      • Not yet recruiting
      • CHU de Nice - Hôpital Archet II
      • Contact: Geoffroy Vanbiervliet, MD; Phone Number: +33 (0)4 92 03 60 18; Email: vanbiervliet.g@chu-nice.fr
      • Contact: Céline Baud; Phone Number: +33 (0)4 92 03 59 72; Email: baud.c@chu-nice.fr
      • Principal Investigator: Geoffroy Vanbiervliet, MD
      • Sub-Investigator: Clément Fortier Beaulieu, MD
  • Rhône-Alpes
    • Lyon, Rhône-Alpes, France, 69000
      • Recruiting
      • Hôpital Edouard Herriot - Hospices civils de Lyon
      • Contact: Jean-Christophe Saurin, Pr; Phone Number: +33 (0)4 72 11 75 72; Email: jean-christophe.saurin@chu-lyon.fr
      • Principal Investigator: Jean-Christophe Saurin, Pr
      • Contact: Olivier Vinet, PhD; Email: olivier.vinet@chu-lyon.fr
    • Saint-Priest-en-Jarez, Rhône-Alpes, France, 42270
      • Recruiting
      • CHU de Saint-Etienne - Hôpital Nord
      • Contact: Emilie Del Tedesco, MD; Phone Number: +33 (0)4 77 82 90 78; Email: emilie.deltedesco@chu-st-etienne.fr
      • Contact: Dupin Mélanie; Phone Number: +33 (0)4 77 82 88 75; Email: Melanie.Dupin@chu-st-etienne.fr
      • Principal Investigator: Emilie Del Tedesco, MD
      • Sub-Investigator: Nicolas Williet, MD

Participation Criteria

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	3 years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complication rate	Percentage of patient having experienced a significant complication from any screening strategy	3 years
Comparison of the strategies cost	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	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

• Sponsor: Hôpital Edouard Herriot
• Collaborators: Medtronic; National Cancer Institute, France
• Investigators: 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

Study Major Dates

• Study Start (Actual): November 3, 2017
• Primary Completion (Actual): November 1, 2021
• Study Completion (Estimated): November 1, 2024

Study Registration Dates

• First Submitted: April 11, 2016
• First Submitted That Met QC Criteria: April 11, 2016
• First Posted (Estimated): April 14, 2016

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: colonoscopy; colon cancer; rectum cancer; colon capsule; fecal immunological test
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Rectal Neoplasms; Colonic Neoplasms
• Other Study ID 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