Liver Diseases, AlcoholicCALMETNCT01237574
Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease
An observational study of Liver Diseases, Alcoholic and Metabolic Diseases, run by University Hospital, Bordeaux at 36 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Liver Diseases, Alcoholic, Metabolic Diseases
- How many people
- 527 participants
- Where
- 36 sitesFrance
- Study dates
- 23 Nov 2010to 12 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
36 sites in 1 country.
36 sites in 1 country
France36 sites
CHU d'Angers
Angers
CHU de Besançon - Hôpital Jean Minjoz
Besançon
CH Pierre Oudot
Bourgoin
CHU de Brest - Hôpital La Cavale Blanche
Brest
CHU de Caen
Caen
CH de Chateauroux
Châteauroux
CHU Clermont-Ferrand - Hôpital Estaing
Clermont-Ferrand
CH Laennec
Creil
CHU de Grenoble - Hôpital Albert Michallon
Grenoble
CH Le Mans
Le Mans
GH-ICL - Hôpital Saint Philibert
Lille
CH de Limoges - Hôpital Dupuytren
Limoges
HCL - Hôpital Hôtel Dieu
Lyon
APHM - Hôpital La Conception
Marseille
Hôpital Saint-Joseph
Marseille
CH de Montauban
Montauban
CHU de Nancy - Hôpital de Brabois
Nancy
CHU de Nice - Hôpital Archet 2
Nice
Hôpital Carémeau
Nîmes
CHR Orléans - Hôpital La Source
Orléans
APHP - Hôpital Bicêtre
Paris
APHP - Hôpital Jean Verdier
Paris
APHP - Hôpital Paul Brousse
Paris
APHP - Hôpital Pitié Salpetrière
Paris
APHP - Hôpital Saint-Antoine
Paris
APHP - Hôpital Tenon
Paris
APHP Hôpital Cochin
Paris
APHP- CHU Henri Mondor
Paris
CH de Perpignan - Hôpital Saint-Jean
Perpignan
CHU de Bordeaux - Hôpital du Haut-Lévêque
Pessac, 33604
CHRU de Poitiers
Poitiers
CHU de Reims - Hôpital Robert Debré
Reims
CHU de Rouen
Rouen
CHRU de Strasbourg - Nouvel Hôpital Civil
Strasbourg
CHU de Toulouse - Hôpital Purpan
Toulouse
CHRU de Tours - Hôpital Trousseau
Tours
About this study
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. ..).
Read the 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.
- Conditions
- Liver Diseases, Alcoholic, Metabolic Diseases
- Being tested
- Intervention according to the standard of care.
- Keywords
- Liver Diseases, Alcoholic, Metabolic Diseases, cohort, liver disease
- Medical subject headings
- Liver Diseases, Alcoholic, Metabolic Diseases, Liver Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention according to the standard of care.Other
Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients with chronic alcoholic and/or metabolic liver disease Receives: Other: Intervention according to the standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death
Measured: up to 84 months
Secondary outcomes (3)
Complications of liver disease
ascites, encephalopathy, liver cancer, bleeding from oesophageal varices
Measured: up to 84 months
Complications of obesity
cardiovascular diseases, pulmonary diseases, etc.
Measured: up to 84 months
Complications of diabetes
renal failure,etc.
Measured: up to 84 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2010 (estimated)
- Study start23 Nov 2010
- Primary completion12 Dec 2020
- Study completion12 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Liver Diseases, AlcoholicStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 527 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01237574
- Sponsor's protocol ID
- CHUBX 2010/38
- Acronym
- CALMET
- Status last verified
- Mar 2021
- First submitted
- 25 Oct 2010
- Last updated
- 26 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre Prospective Cohort Study of Patients With Chronic Alcoholic and/or Metabolic Liver Disease
- ClinicalTrials.gov ID
- NCT01237574
- Acronym / sponsor ID
- CALMET / CHUBX 2010/38
- Conditions
- Liver Diseases, Alcoholic, Metabolic Diseases
- Keywords
- Liver Diseases, Alcoholic, Metabolic Diseases, cohort, liver disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 527 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 23 Nov 2010 (actual)
- Primary completion
- 12 Dec 2020 (actual)
- Study completion
- 12 Dec 2020 (actual)
- First posted
- 9 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. ..).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Other: Intervention according to the standard of care.Patients with chronic alcoholic and/or metabolic liver disease |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- short term life threatening disease
- Other cirrhosis causes
- Impossibility of regular follow-up
- Under guardianship major Patient
- Presence of focal hurt suggestive of CHC
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention according to the standard of care.Every 6 months, patients will have clinical, biological and morphological evaluation according to the standard of care. | Other | Patients |
Primary outcome
Death
Time frame: up to 84 months
3 secondary outcomes
Complications of liver disease
Time frame: up to 84 months
Complications of obesity
Time frame: up to 84 months
Complications of diabetes
Time frame: up to 84 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
36 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Liver Diseases, Alcoholic and Metabolic Diseases, run by University Hospital, Bordeaux at 36 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Mar 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 36 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Death (time frame: up to 84 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Mar 2021.