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 November 2014 by University Hospital, Bordeaux
Sponsor:
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT01237574
First received: October 25, 2010
Last updated: November 6, 2014
Last verified: November 2014
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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
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 Antoine-Beclere | Recruiting |
| Paris, France | |
| Contact: Gabriel PERMLEMUTER, Dr | |
| Principal Investigator: Gabriel PERMLEMUTER, Pr | |
| APHP - Hôpital Bicêtre | Recruiting |
| Paris, France | |
| Contact: Catherine BUFFET, Pr | |
| Principal Investigator: Catherine BUFFET, Pr | |
| APHP - Hôpital Jean Verdier | Recruiting |
| Paris, France | |
| Contact: Jean-Claude TRINCHET, Pr | |
| Principal Investigator: Jean-CLaude Trinchet, Pr | |
| APHP - Hôpital Pitié Salpetrière | Recruiting |
| Paris, France | |
| Contact: Vlad RATZIU, Pr | |
| Principal Investigator: Vlad RATZIU, Pr | |
| APHP - Hôpital Saint-Antoine | Recruiting |
| Paris, France | |
| Contact: Lawrence SERFATY, Dr | |
| Principal Investigator: Lawrence SERFATY, Dr | |
| APHP - Hôpital Tenon | Recruiting |
| Paris, France | |
| Contact: Jean-Didier GRANGE, Pr | |
| Principal Investigator: Jean-Didier GRANGE, Pr | |
| APHP - Hôpital Paul Brousse | Recruiting |
| Paris, France | |
| Contact: Jean-Charles DUCLOS-VALLEE, Pr | |
| Principal Investigator: Jean-charles DUCLOS-VALLEE, Pr | |
| APHP Hôpital Cochin | Recruiting |
| Paris, France | |
| Contact: Stanislas POL, Pr | |
| Principal Investigator: Stanislas POL, 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: | November 6, 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 Alcohol-Induced Disorders |
Alcohol-Related Disorders Chemically-Induced Disorders Digestive System Diseases Substance-Related Disorders |
ClinicalTrials.gov processed this record on March 03, 2015