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NCT01816438 Clinical Trial

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

Dysplasia Clinical Trial

Official title:
A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01816438
Other study ID # SFED N°100
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date July 2013
Est. completion date July 2024

Study information
Verified date September 2023
Source Hôpital Edouard Herriot
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.

Description:

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

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 300
Est. completion date July 2024
Est. primary completion date July 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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

Related Conditions & MeSH terms

Locations
Country Name City State
France Edouard Herriot Hospital Lyon Rhône Alpes

Sponsors (1)
Lead Sponsor Collaborator
Hôpital Edouard Herriot

Country where clinical trial is conducted

France, 

Outcome
Type Measure Description Time frame Safety issue
Primary endoscopies results 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 4 years
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