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Trial record 1 of 1 for:    02738359
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Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening (FAMCAP)

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ClinicalTrials.gov Identifier: NCT02738359
Recruitment Status : Recruiting
First Posted : April 14, 2016
Last Update Posted : August 2, 2018
Sponsor:
Collaborators:
National Cancer Institute, France
Medtronic
Information provided by (Responsible Party):
Jean Christophe Saurin, Hôpital Edouard Herriot

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.

Condition or disease Intervention/treatment
Colon Cancer Rectum Cancer 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 [Patient Registry]
Estimated Enrollment : 3250 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
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.
Actual Study Start Date : November 3, 2017
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


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)




Primary Outcome Measures :
  1. 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%.


Secondary Outcome Measures :
  1. 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.


Other Outcome Measures:
  1. Complication rate [ Time Frame: 3 years ]
    Percentage of patient having experienced a significant complication from any screening strategy

  2. 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. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02738359


Contacts
Contact: Jean-Christophe Saurin, Pr +33 (0)4 72 11 75 72 jean-christophe.saurin@chu-lyon.fr
Contact: Chloé Chavignon, PhD +33 (0)4 72 11 12 91 chloe.chavignon@chu-lyon.fr

Locations
France
CH Colmar Withdrawn
Colmar, Alsace, France, 68000
CHU de Bordeaux - Hôpital Haut-Lévêque Active, not recruiting
Pessac, Aquitaine, France, 33604
CHU de Dijon Not yet recruiting
Dijon, Bourgogne, France, 21000
Contact: Sylvain Manfredi, MD    +33 (0)3 80 39 34 07    sylvain.manfredi@chu-dijon.fr   
Contact: Nora Perrot, IRC    +33 (0)3 80 28 12 66    nora.perrot@chu-dijon.fr   
Principal Investigator: Sylvain Manfredi, MD         
Sub-Investigator: Côme Lepage, Pr         
CHU de Brest - Hôpital de la Cavale Blanche Active, not recruiting
Brest, Bretagne, France, 29200
CHU de Rennes - Hôpital Pontchaillou Recruiting
Rennes, Bretagne, France, 35000
Contact: Astrid Lièvre, Pr    +33(0)2 99 28 43 47    astrid.lievre@chu-rennes.fr   
Contact: Sandrine Simon    +33(0)2 99 28 98 89 Poste85671    sandrine.simon@chu-rennes.fr   
Principal Investigator: Astrid Lièvre, Pr         
CHU de Besançon - Hôpital Minjoz Not yet recruiting
Besançon, Franche-Comté, France, 25030
Contact: Stéphane Koch, MD       skoch@chu-besancon.fr   
Principal Investigator: Stéphane Koch, MD         
Hôpital Avicenne - AP-HP Active, not recruiting
Bobigny, Ile-de-France, France, 93000
CHI de Créteil Active, not recruiting
Créteil, Ile-de-France, France, 94000
Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris Recruiting
Paris, Ile-de-France, France, 75012
Contact: Xavier Dray, Pr    +33 (0)1 49 28 21 60    xavier.dray@lrb.aphp.fr   
Contact: Fouzia Djenadi    +33 (0)1 49 28 22 02    endoscopiesat.urcest@aphp.fr   
Principal Investigator: Xavier Dray, Pr         
Hôpital Cochin - AP-HP Not yet recruiting
Paris, Ile-de-France, France, 75014
Contact: Stanislas Chaussade, Pr         
Principal Investigator: Stanislas Chaussade, Pr         
CHU de Limoges - Hôpital Dupuytren Not yet recruiting
Limoges, Limousin, France, 87000
Contact: Jérémie Jacques, MD    +33 (0)5 55 05 87 72    jeremiejacques@gmail.com   
Principal Investigator: Jérémie Jacques, MD         
Sub-Investigator: Denis Sauterau, Pr         
Sub-Investigator: Anne Le Sidaner, MD         
Sub-Investigator: Romain Legros, MD         
CHU de Toulouse Not yet recruiting
Toulouse, Midi-Pyrénées, France, 31059
Contact: Karl Barange, MD    +33 (0)5 61 77 25 27    barange.k@chu-toulouse.fr   
Principal Investigator: Karl Barange, MD         
CHU de Rouen - Hôpital Charles Nicolle Not yet recruiting
Rouen, Normandie, France, 16000
Contact: Stéphane Lecleire, MD    +33 (0)2 32 88 85 58    stephane.lecleire@chu-rouen.fr   
Principal Investigator: Stéphane Lecleire, MD         
CHU de Nantes - Hôpital de l'Hôtel-Dieu Active, not recruiting
Nantes, Pays De La Loire, France, 44000
CHU de Nice - Hôpital Archet II Not yet recruiting
Nice, Provence-Alpes-Côte d'Azure, France, 06200
Contact: Geoffroy Vanbiervliet, MD    +33 (0)4 92 03 60 18    vanbiervliet.g@chu-nice.fr   
Contact: Céline Baud    +33 (0)4 92 03 59 72    baud.c@chu-nice.fr   
Principal Investigator: Geoffroy Vanbiervliet, MD         
Sub-Investigator: Clément Fortier Beaulieu, MD         
CH d'Avignon Recruiting
Avignon, Provence-Alpes-Côte d'Azur, France, 84000
Contact: Slim Bramli, MD    +33 (0)4 32 75 33 91    sbramli@ch-avignon.fr   
Contact: Marilyne Grinand    +33 (0)4 32 75 93 92    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         
Hôpital de la Timone - AP-HM Not yet recruiting
Marseille, Provence-Alpes-Côte d'Azur, France, 13385
Contact: Philippe Grandval, MD    +33 (0)4 91 38 60 23    philippe.grandval@ap-hm.fr   
Principal Investigator: Philippe Grandval, MD         
Hôpital Edouard Herriot - Hospices civils de Lyon Recruiting
Lyon, Rhône-Alpes, France, 69000
Contact: Jean-Christophe Saurin, Pr    +33 (0)4 72 11 75 72    jean-christophe.saurin@chu-lyon.fr   
Contact: Chloé Chavignon, PhD    +33 (0)4 72 11 03 70    chloe.chavignont@chu-lyon.fr   
Principal Investigator: Jean-Christophe Saurin, Pr         
CHU de Saint-Etienne - Hôpital nord Recruiting
Saint-Priest-en-Jarez, Rhône-Alpes, France, 42270
Contact: Emilie Del Tedesco, MD    +33 (0)4 77 82 90 78    emilie.deltedesco@chu-st-etienne.fr   
Contact: Dupin Mélanie    +33 (0)4 77 82 88 75    Melanie.Dupin@chu-st-etienne.fr   
Sub-Investigator: Nicolas Williet, MD         
Principal Investigator: Emilie Del Tedesco, MD         
Sponsors and Collaborators
Hôpital Edouard Herriot
National Cancer Institute, France
Medtronic
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 Documents (Full-Text)

Documents provided by Jean Christophe Saurin, Hôpital Edouard Herriot:
Study Protocol  [PDF] July 11, 2017


Additional Information:

Responsible Party: Jean Christophe Saurin, Professor, Hôpital Edouard Herriot
ClinicalTrials.gov Identifier: NCT02738359     History of Changes
Other Study ID Numbers: FAMCAP
First Posted: April 14, 2016    Key Record Dates
Last Update Posted: August 2, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Jean Christophe Saurin, Hôpital Edouard Herriot:
colon cancer
rectum cancer
colonoscopy
fecal immunological test
colon capsule

Additional relevant MeSH terms:
Colorectal Neoplasms
Colonic Neoplasms
Rectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
Intestinal Diseases
Rectal Diseases