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

Sponsor
Hôpital Edouard Herriot (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01816438
Collaborator
(none)
300
Enrollment
1
Location
96
Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

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

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    A French Non Interventional Multicentric Cohort Study in Patients With Colorectal Dysplasia in Intestinal Inflammatory Diseases
    Study Start Date :
    Jul 1, 2013
    Actual Primary Completion Date :
    Jul 1, 2020
    Anticipated Study Completion Date :
    Jul 1, 2021

    Arms and Interventions

    Arm Intervention/Treatment
    dysplasia or colorectal lesion

    300 patients

    Outcome Measures

    Primary Outcome Measures

    1. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 80 Years
    Sexes Eligible for Study:
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Edouard Herriot Hospital Lyon Rhône Alpes France 69473

    Sponsors and Collaborators

    • Hôpital Edouard Herriot

    Investigators

    • Principal Investigator: Saurin Jean Christophe, MSD, no affiliated

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jean Christophe Saurin, Professor, Hôpital Edouard Herriot
    ClinicalTrials.gov Identifier:
    NCT01816438
    Other Study ID Numbers:
    • SFED N°100
    First Posted:
    Mar 22, 2013
    Last Update Posted:
    Feb 10, 2021
    Last Verified:
    Feb 1, 2021
    Keywords provided by Jean Christophe Saurin, Professor, Hôpital Edouard Herriot
    abnormal histological colorectal lesions
    Additional relevant MeSH terms:
    Hyperplasia

    Study Results

    No Results Posted as of Feb 10, 2021