Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease
CALMET
1 other identifier
observational
527
1 country
36
Brief Summary
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. ..).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2010
Longer than P75 for all trials
36 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 25, 2010
CompletedFirst Posted
Study publicly available on registry
November 9, 2010
CompletedStudy Start
First participant enrolled
November 23, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 12, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 12, 2020
CompletedMarch 26, 2021
March 1, 2021
10.1 years
October 25, 2010
March 25, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Death
up to 84 months
Secondary Outcomes (3)
Complications of liver disease
up to 84 months
Complications of obesity
up to 84 months
Complications of diabetes
up to 84 months
Study Arms (1)
Patients
Patients with chronic alcoholic and/or metabolic liver disease
Interventions
Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (36)
CHU d'Angers
Angers, France
CHU de Besançon - Hôpital Jean Minjoz
Besançon, France
CH Pierre Oudot
Bourgoin, France
CHU de Brest - Hôpital La Cavale Blanche
Brest, France
CHU de Caen
Caen, France
CH de Chateauroux
Châteauroux, France
CHU Clermont-Ferrand - Hôpital Estaing
Clermont-Ferrand, France
CH Laennec
Creil, France
CHU de Grenoble - Hôpital Albert Michallon
Grenoble, France
CH Le Mans
Le Mans, France
GH-ICL - Hôpital Saint Philibert
Lille, France
CH de Limoges - Hôpital Dupuytren
Limoges, France
HCL - Hôpital Hôtel Dieu
Lyon, France
APHM - Hôpital La Conception
Marseille, France
Hôpital Saint-Joseph
Marseille, France
CH de Montauban
Montauban, France
CHU de Nancy - Hôpital de Brabois
Nancy, France
CHU de Nice - Hôpital Archet 2
Nice, France
Hôpital Carémeau
Nîmes, France
CHR Orléans - Hôpital La Source
Orléans, France
APHP - Hôpital Bicêtre
Paris, France
APHP - Hôpital Jean Verdier
Paris, France
APHP - Hôpital Paul Brousse
Paris, France
APHP - Hôpital Pitié Salpetrière
Paris, France
APHP - Hôpital Saint-Antoine
Paris, France
APHP - Hôpital Tenon
Paris, France
APHP Hôpital Cochin
Paris, France
APHP- CHU Henri Mondor
Paris, France
CH de Perpignan - Hôpital Saint-Jean
Perpignan, France
CHU de Bordeaux - Hôpital du Haut-Lévêque
Pessac, 33604, France
CHRU de Poitiers
Poitiers, France
CHU de Reims - Hôpital Robert Debré
Reims, France
CHU de Rouen
Rouen, France
CHRU de Strasbourg - Nouvel Hôpital Civil
Strasbourg, France
CHU de Toulouse - Hôpital Purpan
Toulouse, France
CHRU de Tours - Hôpital Trousseau
Tours, France
Biospecimen
* serum * plasma (DNA)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 25, 2010
First Posted
November 9, 2010
Study Start
November 23, 2010
Primary Completion
December 12, 2020
Study Completion
December 12, 2020
Last Updated
March 26, 2021
Record last verified: 2021-03