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Identification of High Risk People for Colorectal Cancer and Evaluation of a Specific Surveillance System

Identification of High Risk People for Colorectal Cancer in Indre-et-Loire (France) and Evaluation of a Specific Surveillance System : a Randomized Trial Assessing the Efficacy of a Letter Encouraging People to Perform Colonoscopy Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02931825
Acronym
ISIRECC
Enrollment
7101
Registered
2016-10-13
Start date
2017-05-23
Completion date
2019-05-23
Last updated
2019-05-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cancer Colorectal

Keywords

high risk, surveillance, screening, colonoscopy

Brief summary

Colorectal cancer is one the most frequent cancer in developed countries. In France, it rank third with 43000 new cases in 2015. French Health Authority recommended colonoscopy screening for people with a high risk for colorectal cancer. But this compliance with colonoscopy is low (20-40%), it is therefore necessary to develop new strategies to improve compliance. The purpose of this project is to to offer and evaluate the feasibility and the effectiveness of a specific surveillance system for high risk people for colorectal cancer The project will be divided into 2 phases: Objectives of the first phase: * Identify high risk people for colorectal cancer in the department of Indre-et-Loire, * Fill in as completely as possible their colonoscopic history in the past 5 years, * Estimate the proportion of high risk people for colorectal cancer in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years). Objective of the second phase: Compare the performed colonoscopy rate of high risk people for colorectal cancer without notion of colonoscopy in the past 58 months following or not (control group) the sending of a letter reminding the importance of compliance with colonoscopy.

Interventions

BEHAVIORALReminder letter

The letter will consist in several parts: * Reminder of : -the need of individual follow-up for high risk people for colorectal cancer AND - the general recommendations (one colonoscopy every 5 years) * Recommendation to consult their general practitioner or gastroenterologist if they haven't done their follow up * Request information if they've done their follow-up or if we have incorrect information * Indication that the letter is sent as part of a surveillance program specific for high risk people for colorectal Cancer

Sponsors

University Hospital, Tours
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 74 Years
Healthy volunteers
No

Inclusion criteria

* residing in Indre et Loire (France) * with increased risk for colorectal cancer * who did not perform a colonoscopy in the past 58 months

Exclusion criteria

\- none

Design outcomes

Primary

MeasureTime frame
Calculate the rate of high risk people for colorectal cancer identified in the target population for colorectal cancer screening in Indre-et-Loire (Men and women aged from 50 to 74 years)one year
Comparison of the performed colonoscopy rate within 12 months following randomization / send letter in the 2 arms12 months after sending the letter (/randomization)

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026