Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy (Tempo-colo)
Primary Purpose
Colorectal Cancer
Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Tempo Colo
Sponsored by
About this trial
This is an interventional screening trial for Colorectal Cancer focused on measuring mass screening, colonoscopy surveillance, high risk patients
Eligibility Criteria
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
Sites / Locations
- Adémas-69
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Tempo Colo
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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.
Full Information
NCT ID
NCT03383367
First Posted
December 1, 2017
Last Updated
December 22, 2017
Sponsor
Association pour le Dépistage Organisé des Cancers dans le Rhône
Collaborators
National Cancer Institute, France
1. Study Identification
Unique Protocol Identification Number
NCT03383367
Brief Title
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Unknown status
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Association pour le Dépistage Organisé des Cancers dans le Rhône
Collaborators
National Cancer Institute, France
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
mass screening, colonoscopy surveillance, high risk patients
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective interventional study to evaluate the impact of a reminder sent by the Adémas-69 organization to improve coloscopy surveillance and compliance with recommendations for high risk of colorectal cancer people.
Masking
None (Open Label)
Allocation
N/A
Enrollment
33000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Tempo Colo
Arm Type
Experimental
Intervention Type
Behavioral
Intervention Name(s)
Tempo Colo
Intervention Description
Reminder letter for people at high risk of colorectal cancer.
Primary Outcome Measure Information:
Title
participation rate at future colonoscopy
Description
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.
Time Frame
At time of evaluation we will check the colonoscopy realized at six months after sending the letter at the person
Secondary Outcome Measure Information:
Title
description of lesions severities found at surveillance colonoscopy after letter reminder
Description
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.
Time Frame
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. .
Title
Cost-utility analysis of the reminder letter for surveillance colonoscopy
Description
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.
Time Frame
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Adémas-69
City
Lyon
State/Province
Rhône
ZIP/Postal Code
69005
Country
France
12. IPD Sharing Statement
Learn more about this trial
Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy
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