Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy

Colorectal Cancer Clinical Trial

— Tempo-colo  

Official title:

Extending the Prerogatives of Colorectal Cancer Screening French Organizations to the Follow-up After Colonoscopy of Patients Aged 50 or More: Pilot Study in the Rhône Administrative Department

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT03383367
• Other study ID #: 2016-A01710-51
• Status: Enrolling by invitation
• Phase: N/A
• First received: December 1, 2017
• Last updated: December 22, 2017
• Start date: August 24, 2017
• Est. completion date: December 2018

Study information

• Verified date: December 2017
• Source: Association pour le Dépistage Organisé des Cancers dans le Rhône
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

France is one of the European countries where the incidence of colorectal cancer is the highest among cancers for both sexes. Fecal occult blood screening has been implemented since 2008. However, this screening excludes high risk people who have a 10 to 30 % risk of developing a CRC during their lifetime. Colonoscopy follow up of these persons is not organized, and it is up to the attending physician to recall the date of the surveillance colonoscopy. This results in a poor compliance with the recommendations by these people. A postal reminder of the surveillance colonoscopies sent by The French screening organizations to the patients should increase adherence to follow-up recommendations. The colorectal cancer screening organizations will collects from the hepatogastroenterologists (HGE) informations on colonoscopies of people more than 50 years old who live in the Rhone. These informations will allow to send a reminder 3 months before the date recommended by the HGE. Participation rate and timeliness will be assessed, as well as the severity of the lesions found. A medico-economic analysis will also be carried out.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 33000
• Est. completion date: December 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• people aged 50 years or more ;

• at high risk of colorectal cancer ;

• living in Rhône administrative departement or Metropolitan Lyon

Exclusion Criteria:

• person with chronic inflammatory bowel disease

• colorectal cancer in diagnosis or treatment period

Related Conditions & MeSH terms

• Colorectal Cancer
• Colorectal Neoplasms

Intervention

Behavioral:
• Tempo Colo
Reminder letter for people at high risk of colorectal cancer.

Locations

Country	Name	City	State
France	Adémas-69	Lyon	Rhône

Sponsors (2)

Lead Sponsor	Collaborator
Association pour le Dépistage Organisé des Cancers dans le Rhône	National Cancer Institute, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	participation rate at future colonoscopy	participation rate at future colonoscopy that is the number of patient that really have colonoscopy among the patients who receive a reminder letter The systematic registry of colonoscopies will permit to assess if a patient performs it.	At time of evaluation we will check the colonoscopy realized at six months after sending the letter at the person
Secondary	description of lesions severities found at surveillance colonoscopy after letter reminder	We will assess the severity of the lesions found at colonoscopy performed at th right time : level of dysplasia ; size ; histologic characteristics ; numbers of adenoma.	Lesions'severity will be evaluated at 6, 9 or 15 months following the reminder sent according to the colonoscopist's recommendation (1,3 or 5 years after reference exams). By the way of systematic registration. .
Secondary	Cost-utility analysis of the reminder letter for surveillance colonoscopy	French Health Insurance is the point of vue selected for the evaluation. It's a cost-utility analysis. A Markov model will be performed. The data will proceed from litterature and from data registration during the study. A complementary study will be performed specifically if needed.; For the Markov model the data needed : neoplasia, adenocarcinoma, advanced adenoma, reminders costs, treatments costs, examinations costs, organization costs.	Lesions'severity will be evaluated at 6, 9 or 15 months following the reminder sent according to the colonoscopist's recommendation (1,3 or 5 years after reference exams). The costs will be registered at the same time.