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

Colon Cancer Clinical Trial

— FAMCAP  

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02738359
• Other study ID #: FAMCAP
• Status: Recruiting
• Start date: November 3, 2017
• Est. completion date: November 2024

Study information

• Verified date: February 2024
• Source: Hôpital Edouard Herriot
• Contact: Jean-Christophe Saurin, Pr
• Phone: +33 (0)4 72 11 75 72
• Email: jean-christophe.saurin[@]chu-lyon.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 3250
• Est. completion date: November 2024
• Est. primary completion date: November 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Colon Cancer
• Colonic Neoplasms
• Rectal Neoplasms
• Rectum Cancer

Intervention

Procedure:
• optical colonoscopy
optical colonoscopy
• colon capsule endoscopy
colon capsule endoscopy

Diagnostic Test:
• fecal immunological test (FIT)
fecal immunological test (FIT)

Locations

Country	Name	City	State
France	CH d'Avignon	Avignon	Provence-Alpes-Côte d'Azur
France	CHU de Besançon - Hôpital Minjoz	Besançon	Franche-Comté
France	Hôpital Avicenne - AP-HP	Bobigny	Ile-de-France
France	CHU de Brest - Hôpital de la Cavale Blanche	Brest	Bretagne
France	CH Colmar	Colmar	Alsace
France	CHI de Créteil	Créteil	Ile-de-France
France	CHU de Dijon	Dijon	Bourgogne
France	CHU de Limoges - Hôpital Dupuytren	Limoges	Limousin
France	Hôpital Edouard Herriot - Hospices civils de Lyon	Lyon	Rhône-Alpes
France	Hôpital de la Timone - AP-HM	Marseille	Provence-Alpes-Côte d'Azur
France	CHU de Nantes - Hôpital de l'Hôtel-Dieu	Nantes	Pays De La Loire
France	CHU de Nice - Hôpital Archet II	Nice	Provence-Alpes-Côte d'Azure
France	Hôpital Cochin - AP-HP	Paris	Ile-de-France
France	Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris	Paris	Ile-de-France
France	CHU de Bordeaux - Hôpital Haut-Lévêque	Pessac	Aquitaine
France	CHU de Rennes - Hôpital Pontchaillou	Rennes	Bretagne
France	CHU de Rouen - Hôpital Charles Nicolle	Rouen	Normandie
France	CHU de Saint-Etienne - Hôpital nord	Saint-Priest-en-Jarez	Rhône-Alpes
France	CHU de Toulouse	Toulouse	Midi-Pyrénées

Sponsors (3)

Lead Sponsor	Collaborator
Hôpital Edouard Herriot	Medtronic, National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Complication rate	Percentage of patient having experienced a significant complication from any screening strategy	3 years
Other	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
Other	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
Primary	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	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