- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02060565
Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease (PVNIM)
July 19, 2023 updated by: Association HGE CHU Bordeaux Sud
Prognosis Value of Non-invasive Methods for the Diagnosis of Chronic Liver Disease. a Retrospective and Prospective 20-year Follow-up.
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.
Study Overview
Status
Recruiting
Conditions
Detailed Description
All consecutive patients with chronic liver disease will be followed during 20 years.
Study Type
Observational
Enrollment (Estimated)
10000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Victor de Lédinghen, MD, PhD
- Phone Number: 0033557656439
- Email: victor.deledinghen@chu-bordeaux.fr
Study Contact Backup
- Name: Juliette Foucher
- Phone Number: 0033557656439
- Email: juliette.foucher@chu-bordeaux.fr
Study Locations
-
-
-
Pessac, France, 33200
- Recruiting
- Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque
-
Contact:
- Victor de Lédinghen, MD, PhD
- Phone Number: 0033557656439
- Email: victor.deledinghen@chu-bordeaux.fr
-
Contact:
- Juliette Foucher, MD
- Phone Number: 0033557656439
- Email: juliette.foucher@chu-bordeaux.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
all consecutive patients with an age over eighteen and chronic liver disease
Description
Inclusion Criteria:
- chronic hepatitis C
- chronic hepatitis B
- alcohol liver disease
- non alcoholic liver disease
Exclusion Criteria:
- ascitis
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Chronic liver disease
all patients with chronic liver disease followed using non-invasive methods
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Overall survival
Time Frame: 20 years
|
20 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival without liver complications
Time Frame: 20 years
|
20 years
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Survival without liver transplantation
Time Frame: 20 years
|
20 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Chair: Faiza Chermak, MD, Association HGE CHU Bordeaux Sud
- Study Chair: Jean-Baptiste Hiriart, MD, Association HGE CHU Bordeaux Sud
- Study Chair: Juliette Foucher, MD, Association HGE CHU Bordeaux Sud
- Study Director: Victor de Lédinghen, MD, PhD, Association HGE CHU Bordeaux Sud
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
February 1, 2014
Primary Completion (Estimated)
January 1, 2030
Study Completion (Estimated)
February 1, 2034
Study Registration Dates
First Submitted
February 11, 2014
First Submitted That Met QC Criteria
February 11, 2014
First Posted (Estimated)
February 12, 2014
Study Record Updates
Last Update Posted (Actual)
July 20, 2023
Last Update Submitted That Met QC Criteria
July 19, 2023
Last Verified
July 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HL V-0214
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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