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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by University Hospital, Bordeaux
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01237574
First received: October 25, 2010
Last updated: April 1, 2014
Last verified: April 2014
  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 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Complications of liver disease [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    ascites, encephalopathy, liver cancer, bleeding from oesophageal varices

  • Complications of obesity [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    cardiovascular diseases, pulmonary diseases, etc.

  • Complications of diabetes [ Time Frame: up to 36 months ] [ Designated as safety issue: No ]
    renal failure,etc.


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

Estimated Enrollment: 3000
Study Start Date: December 2010
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01237574

Contacts
Contact: Victor de Lédinghen, PH victor.deledinghen@chu-bordeaux.fr

Locations
France
CHU d'Angers Recruiting
Angers, France
Contact: Paul CALES, Pr         
Principal Investigator: Paul CALES, Pr         
CH d'Avignon Recruiting
Avignon, France
Contact: Jean-Pierre ARPURT         
Principal Investigator: Jean-Pierre ARPURT, Dr         
CHU de Besançon - Hôpital Jean Minjoz Recruiting
Besançon, France
Contact: Thierry THEVENOT, Dr         
Principal Investigator: Thierry THEVENOT, Dr         
CH Pierre Oudot Recruiting
Bourgoin, France
Contact: Thierry FONTANGES, Dr         
Principal Investigator: Thierry FONTANGES, Dr         
CHU de Brest - Hôpital La Cavale Blanche Recruiting
Brest, France
Contact: Jean-Baptiste NOUSBAUM         
Principal Investigator: Jean-Baptiste NOUSBAUM, Pr         
CHU de Caen Recruiting
Caen, France
Contact: Thong DAO, Pr         
Principal Investigator: Thong DAO, Pr         
CH de Chateauroux Recruiting
Chateauroux, France
Contact: Thierry SAPEY, Dr         
Principal Investigator: Thierry SAPEY, Dr         
CHU Clermont-Ferrand - Hôpital Estaing Recruiting
Clermont-Ferrand, France
Contact: Armand ABERGEL, Pr         
Principal Investigator: Armand ABERGEL, Pr         
CH Laennec Recruiting
Creil, France
Contact: Jean-François CADRANEL, Pr         
Principal Investigator: Jean-François CADRANEL, Dr         
CHI de Créteil Recruiting
Créteil, France
Contact: Hervé HAGEGE, Dr         
Principal Investigator: Hervé HAGEGE, Dr         
CHU de Dijon - Complexe du Bocage Recruiting
Dijon, France
Contact: Anne MINELLO         
Principal Investigator: Anne MINELLO, Dr         
CHU de Grenoble - Hôpital Albert Michallon Recruiting
Grenoble, France
Contact: Jean-Pierre ZARSKI, Pr         
Principal Investigator: Jean-Pierre ZARSKI, Pr         
CH de Hyères Recruiting
Hyères, France
Contact: Christophe RENOU, Dr         
Principal Investigator: Christophe RENOU, Dr         
CH Le Mans Recruiting
Le Mans, France
Contact: Christophe PILETTE, Pr         
Principal Investigator: Christophe PILETTE, Pr         
GH-ICL - Hôpital Saint Philibert Recruiting
Lille, France
Contact: Damien LUCIDARME, Pr         
Principal Investigator: Damien LUCIDARME, Pr         
CH de Limoges - Hôpital Dupuytren Recruiting
Limoges, France
Contact: Véronique LOUSTAUD-RATTI, Dr         
Principal Investigator: Véronique LOUSTAUD-RATTI, Dr         
HCL - Hôpital Hôtel Dieu Recruiting
Lyon, France
Contact: François BAILLY, Pr         
Principal Investigator: François BAILLY, Pr         
APHM - Hôpital La Conception Recruiting
Marseille, France
Contact: Danielle BOTTA FRIDLUND, Pr         
Principal Investigator: Danielle BOTTA FRIDLUND, Pr         
Hôpital Saint-Joseph Recruiting
Marseille, France
Contact: Marc BOURLIERE, Dr         
Principal Investigator: Marc BOURLIERE, Dr         
CH de Montauban Recruiting
Montauban, France
Contact: Jean-Louis PAYEN, Dr         
Principal Investigator: Jean-Louis PAYEN, Dr         
CHU de Montpellier - Saint Eloi Recruiting
Montpellier, France
Contact: Stéphanie FAURE, Dr         
Principal Investigator: Stéphanie FAURE, Dr         
CHU de Nancy - Hôpital de Brabois Recruiting
Nancy, France
Contact: Jean-Pierre BRONOWICKI, Pr         
Principal Investigator: Jean-Pierre BRONOWICKI, Pr         
CHU de Nice - Hôpital Archet 2 Recruiting
Nice, France
Contact: Rodolphe ANTY, Dr         
Principal Investigator: Rodolphe ANTY, Pr         
Hôpital Carémeau Recruiting
Nimes, France
Contact: Pascal PERNEY, Pr         
Principal Investigator: Pascal PERNEY, Pr         
CHR Orléans - Hôpital La Source Recruiting
Orléans, France
Contact: Xavier CAUSSE, Dr         
Principal Investigator: Xavier CAUSSE, Dr         
APHP- CHU Henri Mondor Recruiting
Paris, France
Contact: Ariane MALLAT, Dr         
Principal Investigator: Ariane MALLAT, Dr         
APHP - Hôpital Saint-Antoine Recruiting
Paris, France
Contact: Lawrence SERFATY, Dr         
Principal Investigator: Lawrence SERFATY, Dr         
APHP - Hôpital Paul Brousse Recruiting
Paris, France
Contact: Jean-Charles DUCLOS-VALLEE, Pr         
Principal Investigator: Jean-charles DUCLOS-VALLEE, Pr         
APHP - Hôpital Pitié Salpetrière Recruiting
Paris, France
Contact: Vlad RATZIU, Pr         
Principal Investigator: Vlad RATZIU, Pr         
APHP - Hôpital Jean Verdier Recruiting
Paris, France
Contact: Jean-Claude TRINCHET, Pr         
Principal Investigator: Jean-CLaude Trinchet, Pr         
APHP - Hôpital Bicêtre Recruiting
Paris, France
Contact: Catherine BUFFET, Pr         
Principal Investigator: Catherine BUFFET, Pr         
APHP - Hôpital Antoine-Beclere Recruiting
Paris, France
Contact: Gabriel PERMLEMUTER, Dr         
Principal Investigator: Gabriel PERMLEMUTER, Pr         
APHP Hôpital Cochin Recruiting
Paris, France
Contact: Stanislas POL, Pr         
Principal Investigator: Stanislas POL, Pr         
APHP - Hôpital Tenon Recruiting
Paris, France
Contact: Jean-Didier GRANGE, Pr         
Principal Investigator: Jean-Didier GRANGE, Pr         
CH de Perpignan - Hôpital Saint-Jean Recruiting
Perpignan, France
Contact: André-Jean REMY, Pr         
Principal Investigator: André-Jean REMY, Pr         
CHU de Bordeaux - Hôpital du Haut-Lévêque Recruiting
Pessac, France, 33604
Contact: Victor de Lédinghen, PH       victor.deledinghen@chu-bordeaux.fr   
Principal Investigator: victor victor.deledinghen@chu-bordeaux.fr, PH         
CHRU de Poitiers Recruiting
Poitiers, France
Contact: Sylvain SILVAIN, Pr         
Principal Investigator: Christine SILVAIN, Pr         
CHU de Reims - Hôpital Robert Debré Recruiting
Reims, France
Contact: Gérard THIEFIN, Pr         
Principal Investigator: Gérard THIEFIN, Pr         
CHU de Rouen Recruiting
Rouen, France
Contact: Hélène MONTIALOUX, Dr         
Principal Investigator: Hélène MONTIALOUX, Dr         
CHRU de Strasbourg - Nouvel Hôpital Civil Recruiting
Strasbourg, France
Contact: Michel DOFFOEL, Pr         
Principal Investigator: Michel DOFFOEL, Pr         
CHU de Toulouse - Hôpital Purpan Recruiting
Toulouse, France
Contact: Christophe BUREAU, Dr         
Principal Investigator: Christophe BUREAU, Dr         
CHRU de Tours - Hôpital Trousseau Recruiting
Tours, France
Contact: Yannick BACQ, Pr         
Principal Investigator: Yannick BACQ, Pr         
Sponsors and Collaborators
University Hospital, Bordeaux
  More Information

No publications provided

Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT01237574     History of Changes
Other Study ID Numbers: CHUBX 2010/38
Study First Received: October 25, 2010
Last Updated: April 1, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

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

ClinicalTrials.gov processed this record on July 20, 2014