Clinical trial NCT03383367: Colorectal Cancer Screening French Organizations for the Follow-up After Colonoscopy
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
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: mass screening
colonoscopy surveillance
high risk patients
Lead sponsor: Association pour le Dépistage Organisé des Cancers dans le Rhône
Sponsor class: OTHER
Collaborators: name: National Cancer Institute, France
First posted: 2017-12-26
Enrollment: 33000
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SCREENING

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.


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

Primary outcomes:
measure: participation rate at future colonoscopy
timeFrame: At time of evaluation we will check the colonoscopy realized at six months after sending the letter at the person
Secondary outcomes:
measure: description of lesions severities found at surveillance colonoscopy after letter reminder
timeFrame: 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. .
measure: Cost-utility analysis of the reminder letter for surveillance colonoscopy
timeFrame: 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.
Other outcomes:
Locations:
city: Lyon
country: France
facility: Adémas-69
state: Rhône
Study officials:
References: