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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01237574
First Posted: November 9, 2010
Last Update Posted: September 8, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University Hospital, Bordeaux
  Purpose

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. ..).


Condition Intervention
Liver Diseases, Alcoholic Metabolic Diseases Other: Intervention according to the standard of care.

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Death [ Time Frame: up to 84 months ]

Secondary Outcome Measures:
  • Complications of liver disease [ Time Frame: up to 84 months ]
    ascites, encephalopathy, liver cancer, bleeding from oesophageal varices

  • Complications of obesity [ Time Frame: up to 84 months ]
    cardiovascular diseases, pulmonary diseases, etc.

  • Complications of diabetes [ Time Frame: up to 84 months ]
    renal failure,etc.


Biospecimen Retention:   Samples With DNA
  • serum
  • plasma (DNA)

Enrollment: 527
Actual Study Start Date: November 1, 2011
Estimated Study Completion Date: November 1, 2022
Estimated Primary Completion Date: November 1, 2022 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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.

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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
  Contacts and Locations
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): NCT01237574


Locations
France
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
Chateauroux, 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
Nimes, 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, France, 33604
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
Sponsors and Collaborators
University Hospital, Bordeaux
  More Information

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01237574     History of Changes
Other Study ID Numbers: CHUBX 2010/38
First Submitted: October 25, 2010
First Posted: November 9, 2010
Last Update Posted: September 8, 2017
Last Verified: September 2017

Keywords provided by University Hospital, Bordeaux:
Liver Diseases
Alcoholic
Metabolic Diseases
cohort
liver disease

Additional relevant MeSH terms:
Liver Diseases
Metabolic Diseases
Liver Diseases, Alcoholic
Digestive System Diseases
Alcohol-Induced Disorders
Alcohol-Related Disorders
Substance-Related Disorders
Chemically-Induced Disorders


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