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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hyperplasia; Dysplasia

Detailed Description

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

• Study Type: Observational
• Enrollment (Estimated): 300

Contacts and Locations

Study Locations

• France
  • Rhône Alpes
    • Lyon, Rhône Alpes, France, 69473
      • Edouard Herriot Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

In France more than 40000 persons are concerned with a high risk of cancer because of ulcerative colitis for example

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
dysplasia or colorectal lesion; 300 patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Hôpital Edouard Herriot
• Investigators: Principal Investigator: Saurin Jean Christophe, MSD, no affiliated

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): July 1, 2023
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: March 20, 2013
• First Submitted That Met QC Criteria: March 21, 2013
• First Posted (Estimated): March 22, 2013

Study Record Updates

• Last Update Posted (Actual): September 21, 2023
• Last Update Submitted That Met QC Criteria: September 18, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: abnormal histological colorectal lesions
• Additional Relevant MeSH Terms: Pathologic Processes; Hyperplasia
• Other Study ID Numbers: SFED N°100