Clincosm LogoSign in Get a demo

PVNIM: Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease

Sponsor
Association HGE CHU Bordeaux Sud (Other)
Overall Status
Recruiting
CT.gov ID
NCT02060565
Collaborator
(none)
10,000
Enrollment
1
Location
240
Anticipated Duration (Months)
41.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The aim of this retrospective and prospective study is to evaluate the 20-year prognosis value of non-invasive methods for the diagnosis of chronic liver disease for predicting survival and complications of cirrhosis.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    All consecutive patients with chronic liver disease will be followed during 20 years.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    10000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Other
    Official Title:
    Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease. a Retrospective and Prospective 20-year Follow-up.
    Actual Study Start Date :
    Feb 1, 2014
    Anticipated Primary Completion Date :
    Jan 1, 2023
    Anticipated Study Completion Date :
    Feb 1, 2034

    Arms and Interventions

    Arm Intervention/Treatment
    Chronic liver disease

    all patients with chronic liver disease followed using non-invasive methods

    Outcome Measures

    Primary Outcome Measures

    1. Overall survival [20 years]

    Secondary Outcome Measures

    1. Survival without liver complications [20 years]

    Other Outcome Measures

    1. Survival without liver transplantation [20 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • chronic hepatitis C

    • chronic hepatitis B

    • alcohol liver disease

    • non alcoholic liver disease

    Exclusion Criteria:
    • ascitis

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque Pessac France 33200

    Sponsors and Collaborators

    • Association HGE CHU Bordeaux Sud

    Investigators

    • Study Chair: Juliette Foucher, MD, Association HGE CHU Bordeaux Sud
    • Study Chair: Faiza Chermak, MD, Association HGE CHU Bordeaux Sud
    • Study Director: Victor de Lédinghen, MD, PhD, Association HGE CHU Bordeaux Sud
    • Study Chair: Jean-Baptiste Hiriart, MD, Association HGE CHU Bordeaux Sud

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Association HGE CHU Bordeaux Sud
    ClinicalTrials.gov Identifier:
    NCT02060565
    Other Study ID Numbers:
    • HL V-0214
    First Posted:
    Feb 12, 2014
    Last Update Posted:
    Jul 26, 2021
    Last Verified:
    Jul 1, 2021
    Keywords provided by Association HGE CHU Bordeaux Sud
    diagnosis
    survival
    non-invasive method
    cirrhosis
    FibroScan
    Additional relevant MeSH terms:
    Liver Diseases

    Study Results

    No Results Posted as of Jul 26, 2021