Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease (CALMET)
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| ClinicalTrials.gov Identifier: NCT01237574 |
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Recruitment Status
:
Active, not recruiting
First Posted
: November 9, 2010
Last Update Posted
: September 8, 2017
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Sponsor:
University Hospital, Bordeaux
Information provided by (Responsible Party):
University Hospital, Bordeaux
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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. ..).
| Condition or disease | Intervention/treatment |
|---|---|
| Liver Diseases, Alcoholic Metabolic Diseases | Other: Intervention according to the standard of care. |
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 |
| Actual Enrollment : | 527 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease |
| Actual Study Start Date : | November 1, 2011 |
| Estimated Primary Completion Date : | November 1, 2022 |
| Estimated Study Completion Date : | November 1, 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Patients
Patients with chronic alcoholic and/or metabolic liver disease
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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.
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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)
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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
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
| Responsible Party: | University Hospital, Bordeaux |
| ClinicalTrials.gov Identifier: | NCT01237574 History of Changes |
| Other Study ID Numbers: |
CHUBX 2010/38 |
| First Posted: | November 9, 2010 Key Record Dates |
| Last Update Posted: | September 8, 2017 |
| Last Verified: | September 2017 |
Keywords provided by University Hospital, Bordeaux:
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Liver Diseases Alcoholic Metabolic Diseases cohort liver disease |
Additional relevant MeSH terms:
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Liver Diseases Metabolic Diseases Liver Diseases, Alcoholic Digestive System Diseases |
Alcohol-Induced Disorders Alcohol-Related Disorders Substance-Related Disorders Chemically-Induced Disorders |