Detail Article

Informations générales (source: ClinicalTrials.gov)

Numéro NCT

NCT02738359 En recrutement IDF

Titre

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. (FAMCAP)

Type

Observational [Patient Registry]

Pathologie

Tumeurs du côlon
Tumeurs du rectum

Phase

Promoteur

Hôpital Edouard Herriot (Voir sur ClinicalTrials)

Date de début

novembre 2017

Date de fin

novembre 2024

Dernière mise à jour

29 juin 2024

Résumé

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.

Détail

Voir le détail 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. Fermer le détail

Etablissements

Les établissements d'Île-de-France ayant mis à jour leurs données Origine et niveau de fiabilité des données
CHI DE CRETEIL	Mathias VIDON	Terminé	21/01/2025 16:39:16	Contacter
Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
AP-HP - Hôpital Saint Antoine	Xavier Dray, Pr	En recrutement IDF		Contact (sur clinicalTrials)
EFS IDF SITE COCHIN	Stanislas Chaussade, Pr	Recrutement non commencé		Contact (sur clinicalTrials)
IFSI AVICENNE (AP-HP)		Active, sans recrutement		Contact (sur clinicalTrials)
Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CH Colmar - 68000 - Colmar - Alsace - France		Annulé		Contact (sur clinicalTrials)
CH d'Avignon - 84000 - Avignon - Provence-Alpes-Côte d'Azur - France	Slim Bramli, MD	En recrutement		Contact (sur clinicalTrials)
CHU de Bordeaux - Hôpital Haut-Lévêque - 33604 - Pessac - Aquitaine - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU de Dijon - 21000 - Dijon - Bourgogne - France	Sylvain Manfredi, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CHU de Limoges - Hôpital Dupuytren - 87000 - Limoges - Limousin - France	Jérémie Jacques, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CHU de Nice - Hôpital Archet II - 06200 - Nice - Provence-Alpes-Côte d'Azure - France	Geoffroy Vanbiervliet, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CHU de Rennes - Hôpital Pontchaillou - 35000 - Rennes - Bretagne - France		Annulé		Contact (sur clinicalTrials)
CHU de Rouen - Hôpital Charles Nicolle - 16000 - Rouen - Normandie - France	Stéphane Lecleire, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Hôpital Edouard Herriot - Hospices civils de Lyon - 69000 - Lyon - Rhône-Alpes - France	Jean-Christophe Saurin, Pr	En recrutement		Contact (sur clinicalTrials)
Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données
CHI de Créteil - 94000 - Créteil - Ile-de-France - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU de Besançon - Hôpital Minjoz - 25030 - Besançon - Franche-Comté - France	Stéphane Koch, MD	Recrutement non commencé		Contact (sur clinicalTrials)
CHU de Brest - Hôpital de la Cavale Blanche - 29200 - Brest - Bretagne - France		Active, sans recrutement		Contact (sur clinicalTrials)
CHU de Saint-Etienne - Hôpital nord - 42270 - Saint-Priest-en-Jarez - Rhône-Alpes - France	Emilie Del Tedesco, MD	En recrutement		Contact (sur clinicalTrials)
CHU de Toulouse - 31059 - Toulouse - Midi-Pyrénées - France	Karl Barange, MD	Recrutement non commencé		Contact (sur clinicalTrials)
Hôpital de la Timone - AP-HM - 13385 - Marseille - Provence-Alpes-Côte d'Azur - France	Philippe Grandval, MD	Recrutement non commencé		Contact (sur clinicalTrials)

Critères

Genre

Tous

Nombre d'inclusion

Critère d'inclusion

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

Critère de non inclusion

- 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

NCT02738359 - 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. (FAMCAP)

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Critères
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