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

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ClinicalTrials.gov Identifier: NCT01237574
Recruitment Status : Active, not recruiting
First Posted : November 9, 2010
Last Update Posted : September 13, 2018
Sponsor:
Information provided by (Responsible Party):
University Hospital, Bordeaux

October 25, 2010
November 9, 2010
September 13, 2018
November 1, 2011
November 1, 2022   (Final data collection date for primary outcome measure)
Death [ Time Frame: up to 84 months ]
Death [ Time Frame: up to 36 months ]
Complete list of historical versions of study NCT01237574 on ClinicalTrials.gov Archive Site
  • 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.
  • Complications of liver disease [ Time Frame: up to 36 months ]
    ascites, encephalopathy, liver cancer, bleeding from oesophageal varices
  • Complications of obesity [ Time Frame: up to 36 months ]
    cardiovascular diseases, pulmonary diseases, etc.
  • Complications of diabetes [ Time Frame: up to 36 months ]
    renal failure,etc.
Not Provided
Not Provided
 
Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease
Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease

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. ..).

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:
  • serum
  • plasma (DNA)
Non-Probability Sample
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.
  • Liver Diseases, Alcoholic
  • Metabolic Diseases
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.
Patients
Patients with chronic alcoholic and/or metabolic liver disease
Intervention: Other: Intervention according to the standard of care.
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
527
3000
November 1, 2022
November 1, 2022   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT01237574
CHUBX 2010/38
No
Not Provided
Not Provided
University Hospital, Bordeaux
University Hospital, Bordeaux
Not Provided
Not Provided
University Hospital, Bordeaux
September 2018