A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia

Active, not recruiting

• Conditions: Hyperplasia; Dysplasia

• Registration Number: NCT01816438
• Lead Sponsor: Hôpital Edouard Herriot

Brief Summary

The main purpose is to describe clinical practices nowadays prospectively about patients with a dysplasia diagnosis or another histological lesions.

It will be identified colic situation during the initial colonoscopy after dysplasia diagnosis or atypical lesion.

Also the frequency and the type of monitoring conducted about these patients(surgical and endoscopic treatments).

The main criterion evaluation will be the surgical and endoscopic rates during the time.

The treatments offered such as surgical, endoscopic ones or none of them will be followed.

Finally, the outcome of these patients: stability, lesion disappearance, surgery or development of cancer with frequencies for each of them and relationships with histological abnormal colorectal lesion will be measured.

Detailed Description

A replay centralized pathological lesion slides corresponding to the different lesion will be done

Study Timeline

• Study First Submitted: 2013-03-20
• Study First Submitted QC: 2013-03-21
• Study First Posted: 2013-03-22
• Study Start: 2013-07
• Primary Completion: 2023-07
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-18
• Last Update Posted: 2023-09-21
• Study Completion: 2024-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• intestinal chronic inflammatory disease with at least one lesion such as hyperplasia or no dysplastic scalloped lesion, dysplastic scalloped lesion or low grade dysplasia or high grade dysplasia
• compliant patient
• endoscopic follow possible
• no settler cancer
• no serious pathology such as cancer

Exclusion Criteria

• settler cancer
• serious pathology such as cancer
• no compliant patient
• endoscopic follow not possible

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
endoscopies results	4 years	rates of surgery and endoscopic treatments frequency of development of a cancer or a high grade dysplasia according to a type of abnormal histological colorectal lesion

Trial Locations

Locations (1)

Edouard Herriot Hospital; 🇫🇷 Lyon, Rhône Alpes, France