A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Sponsor
- Hôpital Edouard Herriot
- Enrollment
- 300
- Locations
- 1
- Primary Endpoint
- endoscopies results
Study Overview
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 Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
endoscopies results
Time Frame: 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
Secondary Outcomes
No secondary outcomes reported
Investigators
Jean Christophe Saurin
Professor
Hôpital Edouard Herriot