Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy (Tempo-colo)

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

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.

Study Overview

• Status: Unknown
• Conditions: Colorectal Cancer
• Intervention / Treatment: Behavioral: Tempo Colo

• Study Type: Interventional
• Enrollment (Anticipated): 33000
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rhône
    • Lyon, Rhône, France, 69005
      • Adémas-69

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tempo Colo	Behavioral: Tempo Colo; Reminder letter for people at high risk of colorectal cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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. .
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.

Collaborators and Investigators

• Sponsor: Association pour le Dépistage Organisé des Cancers dans le Rhône
• Collaborators: National Cancer Institute, France

Study record dates

Study Major Dates

• Study Start (Actual): August 24, 2017
• Primary Completion (Anticipated): November 1, 2018
• Study Completion (Anticipated): December 1, 2018

Study Registration Dates

• First Submitted: December 1, 2017
• First Submitted That Met QC Criteria: December 22, 2017
• First Posted (Actual): December 26, 2017

Study Record Updates

• Last Update Posted (Actual): December 26, 2017
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Keywords: high risk patients; mass screening; colonoscopy surveillance
• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms; Neoplasms by Site; Gastrointestinal Neoplasms; Digestive System Neoplasms; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Intestinal Neoplasms; Rectal Diseases; Colorectal Neoplasms; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Antioxidants; TEMPO
• Other Study ID Numbers: 2016-A01710-51

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No