FRESH-PEF60163-en
Multicentric Prospective Cohort Study of Patients with Chronic Alcoholic and/or Metabolic Liver Disease
CALMET
| Name | Country code |
|---|---|
| France | fr |
['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging','Paraclinical data (non-biological) : Anthropometry']
Individuals
| 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 |
{
"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": ""
}
| Name |
|---|
| Victor;DE LEDINGHEN |
| Name | Role |
|---|---|
| CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX | sponsor |
| Name |
|---|
| AGENCE NATIONALE DE LA RECHERCHE (ANR) |
| INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM) |
['Through organizations (health services or institutions, schools, businesses, etc.)']
['{"concept":{"vocabURI":"Other","vocab":"CESSDA"},"value":"Other"}']
Access on specific project only
Observational Study
| Start | End |
|---|---|
| 2011-01-01 | 2018-01-01 |
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.
{"value":"Restricted access","extLink":[{"title":"COAR","uri":"http://purl.org/coar/access_right/c_16ec"}]}
Data may be used by academic teams. Data may not be used by industrial teams.
| Name | |
|---|---|
| Victor;DE LEDINGHEN | victor.deledinghen@chu-bordeaux.fr |
FRESH-PEF60163-en
| Name | Affiliation |
|---|---|
| Victor DE LEDINGHEN | CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX |