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

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ClinicalTrials.gov Identifier: NCT02060565
Recruitment Status : Recruiting
First Posted : February 12, 2014
Last Update Posted : July 3, 2019
Sponsor:
Information provided by (Responsible Party):
Association HGE CHU Bordeaux Sud

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
Chronic Liver Disease

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

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Study Type : Observational
Estimated 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.
Study Start Date : February 2014
Estimated Primary Completion Date : January 2023
Estimated Study Completion Date : February 2034

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Liver Diseases

Group/Cohort
Chronic liver disease
all patients with chronic liver disease followed using non-invasive methods



Primary Outcome Measures :
  1. Overall survival [ Time Frame: 20 years ]

Secondary Outcome Measures :
  1. Survival without liver complications [ Time Frame: 20 years ]

Other Outcome Measures:
  1. Survival without liver transplantation [ Time Frame: 20 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
all consecutive patients with an age over eighteen and chronic liver disease
Criteria

Inclusion Criteria:

  • chronic hepatitis C
  • chronic hepatitis B
  • alcohol liver disease
  • non alcoholic liver disease

Exclusion Criteria:

  • ascitis

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02060565


Contacts
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Contact: Victor de Lédinghen, MD, PhD 0033557656439 victor.deledinghen@chu-bordeaux.fr
Contact: Julien Vergniol 0033557656439 julien.vergniol@chu-bordeaux.fr

Locations
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France
Centre d'Investigation de la Fibrose hépatique Service Hépato-Gastroentérologie Hopital Haut-Lévèque Recruiting
Pessac, France, 33200
Contact: Victor de Lédinghen, MD, PhD    0033557656439    victor.deledinghen@chu-bordeaux.fr   
Contact: Julien Vergniol, MD    0033557656439    julien.vergniol@chu-bordeaux.fr   
Sponsors and Collaborators
Association HGE CHU Bordeaux Sud
Investigators
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Principal Investigator: Julien Vergniol, MD Association HGE CHU Bordeaux Sud
Study Chair: Juliette Foucher, MD Association HGE CHU Bordeaux Sud
Study Chair: Faiza Chermak, MD Association HGE CHU Bordeaux Sud
Study Chair: Wassil Merrouche Association HGE CHU Bordeaux Sud
Study Director: Victor de Lédinghen, MD, PhD Association HGE CHU Bordeaux Sud
Study Chair: Pierre-Henri Bernard, MD Association HGE CHU Bordeaux Sud
Study Chair: Jean-Baptiste Hiriart, MD Association HGE CHU Bordeaux Sud

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Responsible Party: Association HGE CHU Bordeaux Sud
ClinicalTrials.gov Identifier: NCT02060565     History of Changes
Other Study ID Numbers: HL V-0214
First Posted: February 12, 2014    Key Record Dates
Last Update Posted: July 3, 2019
Last Verified: July 2019

Keywords provided by Association HGE CHU Bordeaux Sud:
diagnosis
survival
non-invasive method
cirrhosis
FibroScan

Additional relevant MeSH terms:
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Liver Diseases
Digestive System Diseases