Clinical trial NCT02738359: 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.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Colon Cancer
Rectum Cancer
Keywords: colon cancer
rectum cancer
colonoscopy
fecal immunological test
colon capsule
Lead sponsor: Hôpital Edouard Herriot
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
name: Medtronic
First posted: 2016-04-14
Enrollment: 3250
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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

Primary outcomes:
measure: Prevalence of advanced colorectal neoplasia or cancer identified by each screening strategy (OC, CC and FIT)
timeFrame: 3 years
Secondary outcomes:
measure: Rate of colorectal cancer identified by each screening strategy
timeFrame: 3 years
Other outcomes:
measure: Complication rate
timeFrame: 3 years
measure: Comparison of the strategies cost
timeFrame: 3 years
measure: Quality assessment of colonoscopy and capsule endoscopy
timeFrame: 3 years
Locations:
city: Colmar
country: France
facility: CH Colmar
state: Alsace
city: Pessac
country: France
facility: CHU de Bordeaux - Hôpital Haut-Lévêque
state: Aquitaine
city: Dijon
country: France
facility: CHU de Dijon
state: Bourgogne
city: Brest
country: France
facility: CHU de Brest - Hôpital de la Cavale Blanche
state: Bretagne
city: Rennes
country: France
facility: CHU de Rennes - Hôpital Pontchaillou
state: Bretagne
city: Besançon
country: France
facility: CHU de Besançon - Hôpital Minjoz
state: Franche-Comté
city: Bobigny
country: France
facility: Hôpital Avicenne - AP-HP
state: Ile-de-France
city: Créteil
country: France
facility: CHI de Créteil
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Saint-Antoine - Assistance publique-Hôpitaux de Paris
state: Ile-de-France
city: Paris
country: France
facility: Hôpital Cochin - AP-HP
state: Ile-de-France
city: Limoges
country: France
facility: CHU de Limoges - Hôpital Dupuytren
state: Limousin
city: Toulouse
country: France
facility: CHU de Toulouse
state: Midi-Pyrénées
city: Rouen
country: France
facility: CHU de Rouen - Hôpital Charles Nicolle
state: Normandie
city: Nantes
country: France
facility: CHU de Nantes - Hôpital de l'Hôtel-Dieu
state: Pays De La Loire
city: Nice
country: France
facility: CHU de Nice - Hôpital Archet II
state: Provence-Alpes-Côte d'Azure
city: Avignon
country: France
facility: CH d'Avignon
state: Provence-Alpes-Côte d'Azur
city: Marseille
country: France
facility: Hôpital de la Timone - AP-HM
state: Provence-Alpes-Côte d'Azur
city: Lyon
country: France
facility: Hôpital Edouard Herriot - Hospices civils de Lyon
state: Rhône-Alpes
city: Saint-Priest-en-Jarez
country: France
facility: CHU de Saint-Etienne - Hôpital nord
state: Rhône-Alpes
Study officials:
affiliation: Hôpital Edouard Herriot - Hospices civils de Lyon
name: Jean-Christophe Saurin, Pr
role: PRINCIPAL_INVESTIGATOR
affiliation: Hôpital Avicenne - Assistance publique-Hôpitaux de Paris
name: Robert Benamouzig, Pr
role: STUDY_CHAIR
References: