Efficacy of Colonoscopy, Colon Capsule and Fecal Immunological Test for Colorectal Cancer Screening
- Conditions
- Colon CancerRectum Cancer
- Interventions
- Procedure: optical colonoscopyDiagnostic Test: fecal immunological test (FIT)Procedure: colon capsule endoscopy
- Registration Number
- NCT02738359
- Lead Sponsor
- H么pital 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.
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 3250
Not provided
Not provided
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description 2nd arm: colon capsule endoscopy (CC) optical colonoscopy 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 3rd arm: fecal immunological test (FIT) optical colonoscopy 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 3rd arm: fecal immunological test (FIT) 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 1rst arm: optical colonoscopy (OC) optical colonoscopy t0: optical colonoscopy; Follow-up: yearly by phone call for three years 2nd arm: colon capsule endoscopy (CC) colon capsule endoscopy 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
- Primary Outcome Measures
Name Time Method Prevalence of advanced colorectal neoplasia or cancer identified by each screening strategy (OC, CC and FIT) 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 卤3%.
- Secondary Outcome Measures
Name Time Method Rate of colorectal cancer identified by each screening strategy 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.
Trial Locations
- Locations (19)
CHU de Brest - H么pital de la Cavale Blanche
馃嚝馃嚪Brest, Bretagne, France
CHU de Rennes - H么pital Pontchaillou
馃嚝馃嚪Rennes, Bretagne, France
CH Colmar
馃嚝馃嚪Colmar, Alsace, France
CHU de Bordeaux - H么pital Haut-L茅v锚que
馃嚝馃嚪Pessac, Aquitaine, France
CHU de Dijon
馃嚝馃嚪Dijon, Bourgogne, France
CHU de Besan莽on - H么pital Minjoz
馃嚝馃嚪Besan莽on, Franche-Comt茅, France
H么pital Avicenne - AP-HP
馃嚝馃嚪Bobigny, Ile-de-France, France
H么pital Saint-Antoine - Assistance publique-H么pitaux de Paris
馃嚝馃嚪Paris, Ile-de-France, France
H么pital Cochin - AP-HP
馃嚝馃嚪Paris, Ile-de-France, France
CHI de Cr茅teil
馃嚝馃嚪Cr茅teil, Ile-de-France, France
CHU de Toulouse
馃嚝馃嚪Toulouse, Midi-Pyr茅n茅es, France
CHU de Limoges - H么pital Dupuytren
馃嚝馃嚪Limoges, Limousin, France
CHU de Rouen - H么pital Charles Nicolle
馃嚝馃嚪Rouen, Normandie, France
CHU de Nantes - H么pital de l'H么tel-Dieu
馃嚝馃嚪Nantes, Pays De La Loire, France
CHU de Nice - H么pital Archet II
馃嚝馃嚪Nice, Provence-Alpes-C么te d'Azure, France
CH d'Avignon
馃嚝馃嚪Avignon, Provence-Alpes-C么te d'Azur, France
H么pital de la Timone - AP-HM
馃嚝馃嚪Marseille, Provence-Alpes-C么te d'Azur, France
H么pital Edouard Herriot - Hospices civils de Lyon
馃嚝馃嚪Lyon, Rh么ne-Alpes, France
CHU de Saint-Etienne - H么pital nord
馃嚝馃嚪Saint-Priest-en-Jarez, Rh么ne-Alpes, France