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Multicentric Prospective Cohort Study of Patients with Chronic Alcoholic and/or Metabolic Liver Disease

France, 2011 - 2018
Reference ID
FRESH-PEF60163-en
Producer(s)
Victor;DE LEDINGHEN
Metadata
DDI/XML JSON
Study website Interactive tools
Created on
Feb 18, 2026
Last modified
Feb 18, 2026
Page views
3
  • Study Description
  • Get Microdata
  • Identification
  • Scope
  • Coverage
  • Producers and sponsors
  • Sampling
  • Survey instrument
  • Data collection
  • Study activities
  • Data Access
  • Contacts
  • Metadata production
  • Identification

    Survey ID number

    FRESH-PEF60163-en

    Title

    Multicentric Prospective Cohort Study of Patients with Chronic Alcoholic and/or Metabolic Liver Disease

    Abbreviation or Acronym

    CALMET

    Country
    Name Country code
    France fr
    Kind of Data

    ['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Anthropometry']

    Unit of Analysis

    Individuals

    Scope

    Topics
    Topic Vocabulary
    Endocrinology health theme
    Hepatology health theme
    Hepatic cirrhosis cim-11
    Hepatocellular carcinoma of liver cim-11
    Biological determinants: Genetic predisposition health determinant
    Biological determinants health determinant
    Keywords
    decompensation liver failure portal hypertension cirrhosis gastrointestinal bleeding ascites renal failure encephalopathy guided liver biopsy Health episodes aggravation infection prevention care treatment CHC imaging diagnosis death

    Coverage

    Universe

    {
    "level_sex_clusion_I": [
    {
    "value": "Male",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008297"
    }
    },
    {
    "value": "Female",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D005260"
    }
    }
    ],
    "level_age_clusion_I": [
    {
    "value": "Young Adult (19 to 24 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D055815"
    }
    },
    {
    "value": "Adult (25 to 44 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000328"
    }
    },
    {
    "value": "Middle Aged (45 to 64 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D008875"
    }
    },
    {
    "value": "Aged (65 to 79 years)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000368"
    }
    },
    {
    "value": "Aged, 80 and over (80 years and more)",
    "concept": {
    "vocab": "MeSH",
    "vocabURI": "http:\/\/id.nlm.nih.gov\/mesh\/D000369"
    }
    }
    ],
    "level_type_clusion_I": [
    "Patients population"
    ],
    "level_type_clusion_other": "",
    "clusion_I": "over 18 years of age; - liver disease whose severity was determined by hepatic puncture biopsy (HPB) or non-invasive markers of fibrosis or FibroScan: - HPB with bridging fibrosis or cirrhosis (regardless of the date and method of liver sample); - Fibrotest greater than 0.58 and at least 6 months old - Measurement of liver stiffness by FibroScan greater than 7.9 kPa (with IQR\/LSM less than 0.30) older than 6 months; - no previous decompensated cirrhosis (gastrointestinal bleeding or clinical ascites) or CHC (treated or untreated); - existence of criteria demonstrating a history or continuance of chronic alcohol use, defined by consumption of 30 g per day for men and 20 g per day for women for at least 10 years (more than 21 drinks per week for men and 14 drinks per week for women); - presence of 3 metabolic syndrome criteria: increased waist circumference (greater than 102 cm for men, greater than 88 cm for women), diabetes or elevated fasting blood glucose (greater than or equal to 6.1 mmol \/l), treated or untreated arterial hypertension (greater than or equal to 130\/85 mmHg), decreased HDL cholesterol (less than 1.04 mmol\/l for men, less than 1.28 mmol\/l for women) elevated triglycerides (greater than 1.6 mmol \/l - Lancet 2005); - individuals covered by social security insurance; - who have received clear and honest information regarding the study and given written consent.",
    "clusion_E": ""
    }

    Producers and sponsors

    Primary investigators
    Name
    Victor;DE LEDINGHEN
    Producers
    Name Role
    CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX sponsor
    Funding Agency/Sponsor
    Name
    AGENCE NATIONALE DE LA RECHERCHE (ANR)
    INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)

    Sampling

    Sample frame

    Unit Type

    ['Through organizations (health services or institutions, schools, businesses, etc.)']

    Sampling Procedure

    ['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']

    Survey instrument

    Questionnaires

    Access on specific project only

    Methodology notes

    Observational Study

    Data collection

    Dates of Data Collection
    Start End
    2011-01-01 2018-01-01
    Mode of data collection
    • {"concept":{"vocabURI":"SelfAdministeredQuestionnaire","vocab":"CESSDA"},"value":"Self-administered questionnaire"}
    • {"concept":{"vocabURI":"Interview","vocab":"CESSDA"},"value":"Interview with the participant (including clinical)"}

    Study activities

    Study activities
    Study activities
    Type
    primary evaluation
    Description
    Health event/morbidity Health event/mortality

    Data Access

    Access conditions

    Access for each nested study using clinical data and/or samples collected from the cohort is subject to specific projects that have an indicated link to the cohort. All independent aspects regarding the associated project (clinical data, questionnaires, additional tests, bioassays etc.) will require specific funding. Research projects must first be discussed and approved by the Scientific Council, either at annual meetings, or after distribution via email (if necessary). In any case, clinical data from the common database or stored biological samples can not be used in a study by a member of the Scientific Council or by an investigator (or any other persons) without the consent of the group according to the regulations stated above. In the case of a disagreement regarding the use of data or samples, voting will be carried out in order ​​to choose between the different proposals (rules to be defined). Implementation of nested studies will be subject to prior authorisation and review from the appropriate regulatory bodies.

    Availability Status

    {"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}

    Restrictions

    Data may be used by academic teams. Data may not be used by industrial teams.

    Contacts

    Contacts
    Name Email
    Victor;DE LEDINGHEN victor.deledinghen@chu-bordeaux.fr

    Metadata production

    DDI Document ID

    FRESH-PEF60163-en

    Producers
    Name Affiliation
    Victor DE LEDINGHEN CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX
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