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

March 25, 2021 updated by: University Hospital, Bordeaux

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. ..).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
527

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angers, France
        • CHU d'Angers
      • Besançon, France
        • CHU de Besançon - Hôpital Jean Minjoz
      • Bourgoin, France
        • CH Pierre Oudot
      • Brest, France
        • CHU de Brest - Hôpital La Cavale Blanche
      • Caen, France
        • CHU de Caen
      • Chateauroux, France
        • CH DE CHATEAUROUX
      • Clermont-Ferrand, France
        • CHU Clermont-Ferrand - Hôpital ESTAING
      • Creil, France
        • Ch Laennec
      • Grenoble, France
        • CHU de Grenoble - Hôpital Albert Michallon
      • Le Mans, France
        • CH Le Mans
      • Lille, France
        • GH-ICL - Hôpital Saint Philibert
      • Limoges, France
        • CH de Limoges - Hôpital Dupuytren
      • Lyon, France
        • HCL - Hôpital Hôtel Dieu
      • Marseille, France
        • Hôpital Saint-Joseph
      • Marseille, France
        • APHM - Hôpital La Conception
      • Montauban, France
        • CH de Montauban
      • Nancy, France
        • CHU de Nancy - Hopital de Brabois
      • Nice, France
        • CHU de Nice - Hôpital Archet 2
      • Nimes, France
        • Hopital Caremeau
      • Orléans, France
        • CHR Orleans - Hopital La Source
      • Paris, France
        • APHP Hopital Cochin
      • Paris, France
        • APHP - Hôpital Bicêtre
      • Paris, France
        • APHP - Hôpital Tenon
      • Paris, France
        • APHP - Hôpital Jean Verdier
      • Paris, France
        • APHP - Hôpital Paul Brousse
      • Paris, France
        • Aphp - Hopital Pitie Salpetriere
      • Paris, France
        • APHP - Hôpital Saint-Antoine
      • Paris, France
        • APHP- CHU Henri Mondor
      • Perpignan, France
        • CH de Perpignan - Hôpital Saint-Jean
      • Pessac, France, 33604
        • CHU de Bordeaux - Hôpital du Haut-Lévêque
      • Poitiers, France
        • CHRU de Poitiers
      • Reims, France
        • CHU de Reims - Hôpital Robert Debré
      • Rouen, France
        • CHU de Rouen
      • Strasbourg, France
        • CHRU de Strasbourg - Nouvel Hôpital Civil
      • Toulouse, France
        • CHU de Toulouse - Hôpital Purpan
      • Tours, France
        • CHRU de Tours - Hôpital Trousseau

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Death
Time Frame: up to 84 months
up to 84 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complications of liver disease
Time Frame: up to 84 months
ascites, encephalopathy, liver cancer, bleeding from oesophageal varices
up to 84 months
Complications of obesity
Time Frame: up to 84 months
cardiovascular diseases, pulmonary diseases, etc.
up to 84 months
Complications of diabetes
Time Frame: up to 84 months
renal failure,etc.
up to 84 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Bordeaux

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 23, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 12, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 25, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 8, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 9, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 26, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 25, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHUBX 2010/38

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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