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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

Tracking Information
First Submitted Date April 11, 2016
First Posted Date April 14, 2016
Last Update Posted Date August 2, 2018
Actual Study Start Date November 3, 2017
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 17, 2017)
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%.
Original Primary Outcome Measures
 (submitted: April 11, 2016)
The primary endpoint is the prevalence of advanced colorectal neoplasia (adenoma > 1 cm, adenoma with high grade dysplasia) or cancer identified by each strategy after 3 years [ Time Frame: 3 years ]
Change History
Current Secondary Outcome Measures
 (submitted: March 21, 2018)
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.
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: August 17, 2017)
  • Complication rate [ Time Frame: 3 years ]
    Percentage of patient having experienced a significant complication from any screening strategy
  • 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.
  • 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.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening
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.
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.
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]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 3 Years
Biospecimen Not Provided
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.
Condition
  • Colon Cancer
  • Rectum Cancer
Intervention
  • Procedure: optical colonoscopy
    optical colonoscopy
  • Procedure: colon capsule endoscopy
    colon capsule endoscopy
  • Diagnostic Test: fecal immunological test (FIT)
    fecal immunological test (FIT)
Study Groups/Cohorts
  • 1rst arm: optical colonoscopy (OC)
    t0: optical colonoscopy; Follow-up: yearly by phone call for three years
    Intervention: 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
    Interventions:
    • 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

    Interventions:
    • Procedure: optical colonoscopy
    • Diagnostic Test: fecal immunological test (FIT)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: August 17, 2017)
3250
Original Estimated Enrollment
 (submitted: April 11, 2016)
3000
Estimated Study Completion Date November 2023
Estimated Primary Completion Date November 2020   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 45 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
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
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT02738359
Other Study ID Numbers FAMCAP
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Jean Christophe Saurin, Hôpital Edouard Herriot
Study Sponsor Hôpital Edouard Herriot
Collaborators
  • 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
PRS Account Hôpital Edouard Herriot
Verification Date July 2018