Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease (CALMET)

March 25, 2021 updated by: University Hospital, Bordeaux

Chronic alcoholic and metabolic liver diseases are the two main liver diseases in France. The long-term prognosis of these two diseases are not well known because main studies are retrospective and with only alcoholic patients. The knowledge of the natural history of these diseases should improve the management of patients with such diseases.

The aim of this prospective cohort is to describe the natural history of patients with chronic liver disease due to alcohol or metabolic disease and to identify factors associated with complications of these liver diseases (cirrhosis, hepatocellular carcinoma, ascites. ..).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In 2010, the two most frequent chronic liver diseases are alcoholic and metabolic disease. The natural history of these two diseases is not well known. Indeed, most of the studies were retrospective and evaluated alcoholic disease or metabolic disease but never both diseases. However, these two diseases have the same histological lesions and can be associated. The knowledge of the natural history of these diseases could improve the management of patients in order to decrease complications and improve survival. The aim of this prospective study is to describe the natural history of chronic liver disease due to alcohol and/or metabolic syndrome and to identify factors associated with complications (ascites, encephalopathy, death, complications of obesity, diabetes or chronic alcohol abuse). All patients will be followed every 6 months for 3 years with clinical, biological and morphological parameters.

Study Type

Observational

Enrollment (Actual)

527

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU d'Angers
      • Besançon, France
        • CHU de Besancon - Hopital Jean Minjoz
      • Bourgoin, France
        • CH Pierre Oudot
      • Brest, France
        • CHU de Brest - Hôpital La Cavale Blanche
      • Caen, France
        • CHU de Caen
      • Chateauroux, France
        • CH de Chateauroux
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand - Hôpital ESTAING
      • Creil, France
        • Ch Laennec
      • Grenoble, France
        • CHU de Grenoble - Hopital Albert Michallon
      • Le Mans, France
        • CH Le mans
      • Lille, France
        • GH-ICL - Hôpital Saint Philibert
      • Limoges, France
        • CH de Limoges - Hôpital Dupuytren
      • Lyon, France
        • HCL - Hôpital Hôtel Dieu
      • Marseille, France
        • Höpital Saint-Joseph
      • Marseille, France
        • APHM - Hôpital La Conception
      • Montauban, France
        • CH de Montauban
      • Nancy, France
        • CHU de Nancy - Hopital de Brabois
      • Nice, France
        • CHU de Nice - Hôpital Archet 2
      • Nimes, France
        • Hopital Caremeau
      • Orléans, France
        • CHR Orleans - Hopital La Source
      • Paris, France
        • APHP Hôpital Cochin
      • Paris, France
        • APHP - Hôpital Bicêtre
      • Paris, France
        • APHP - Hôpital Tenon
      • Paris, France
        • APHP - Hôpital Jean Verdier
      • Paris, France
        • APHP - Hôpital Paul Brousse
      • Paris, France
        • Aphp - Hopital Pitie Salpetriere
      • Paris, France
        • APHP - Hôpital Saint-Antoine
      • Paris, France
        • APHP- CHU Henri Mondor
      • Perpignan, France
        • CH de Perpignan - Hôpital Saint-Jean
      • Pessac, France, 33604
        • CHU de Bordeaux - Hôpital du Haut-Lévêque
      • Poitiers, France
        • CHRU de Poitiers
      • Reims, France
        • CHU de Reims - Hôpital Robert Debré
      • Rouen, France
        • CHU de ROUEN
      • Strasbourg, France
        • CHRU de Strasbourg - Nouvel Hôpital Civil
      • Toulouse, France
        • CHU de Toulouse - Hôpital Purpan
      • Tours, France
        • CHRU de Tours - Hôpital Trousseau

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

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

18 years old patient with chronic liver disease (liver biopsy with bridging fibrosis or cirrhosis) or non-invasive markers of fibrosis (fibrotest > 0.58, FibroScan > 7.9 kPa), no decompensated cirrhosis, chronic alcohol use and/or metabolic syndrome.

Description

Inclusion Criteria:

  • Age over 18 years
  • chronic liver disease (liver biopsy with bridging fibrosis or cirrhosis) or non-invasive markers of fibrosis (fibrotest > 0.58, FibroScan > 7.9 kPa)
  • no decompensated cirrhosis
  • chronic alcohol use and/or metabolic syndrome (at least 3 criteria of metabolic syndrome)
  • Written informed consent
  • Patient covered by the French health insurance system

Exclusion Criteria:

  • short term life threatening disease
  • Other cirrhosis causes
  • Impossibility of regular follow-up
  • Under guardianship major Patient
  • Presence of focal hurt suggestive of CHC
  • pregnant women
  • cirrhosis complication
  • Child-pugh score superior or equal to 7

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
Intervention / Treatment
Patients
Patients with chronic alcoholic and/or metabolic liver disease
Other: Intervention according to the standard of care.
Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Death
Time Frame: up to 84 months
up to 84 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Complications of liver disease
Time Frame: up to 84 months
ascites, encephalopathy, liver cancer, bleeding from oesophageal varices
up to 84 months
Complications of obesity
Time Frame: up to 84 months
cardiovascular diseases, pulmonary diseases, etc.
up to 84 months
Complications of diabetes
Time Frame: up to 84 months
renal failure,etc.
up to 84 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Bordeaux

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)

November 23, 2010

Primary Completion (Actual)

December 12, 2020

Study Completion (Actual)

December 12, 2020

Study Registration Dates

First Submitted

October 25, 2010

First Submitted That Met QC Criteria

November 8, 2010

First Posted (Estimate)

November 9, 2010

Study Record Updates

Last Update Posted (Actual)

March 26, 2021

Last Update Submitted That Met QC Criteria

March 25, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHUBX 2010/38

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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