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

NCT01816438 | Unknown

• 1 other identifier: SFED N°100
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Hyperplasia; Dysplasia

Keywords

abnormal histological colorectal lesions

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

dysplasia or colorectal lesion

300 patients

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Hôpital Edouard Herriot: lead

Study Sites (1)

Edouard Herriot Hospital

Lyon, Auvergne-Rhône-Alpes, 69473, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

pathological lesion slides

MeSH Terms

Conditions

Hyperplasia

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Saurin Jean Christophe, MSD

  no affiliated

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 4 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 20, 2013
• First Posted: March 22, 2013
• Study Start: July 1, 2013
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2024
• Last Updated: September 21, 2023

Record last verified: 2023-09

Locations

FR (1)