CIRRAL - Multicentric cohort of patients with compensated and non-complicated alcoholic cirrhosis, designed to study the incidence and predictors of hepatocellular carcinoma (HCC)

Head :
Ganne Nathalie, Hôpital Jean Verdier

Last update : 07/05/2014 | Version : 1 | ID : 60198

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Métadonnées
Identification
General Aspects
Scientific investigator(s) (Contact)
Collaborations
Funding
Governance of the database
Additional contact
Type of database
Database objective
Population type
Dates
Size of the database
Data
Procedures
Promotion
Access
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General
Identification
Detailed name Multicentric cohort of patients with compensated and non-complicated alcoholic cirrhosis, designed to study the incidence and predictors of hepatocellular carcinoma (HCC)
Sign or acronym CIRRAL
CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation Accord CNIL: 12/08/2010
General Aspects
Medical area Cancer research
Health determinants Addictions
Others (details) Cirrhosis, hepatocellular carcinoma
Keywords Alcohol, predictive factors
Scientific investigator(s) (Contact)
Name of the director Ganne
Surname Nathalie
Address Avenue du 14 juillet, 93140 BONDY
Phone +33 (0)1 48 02 62 94
Email nathalie.ganne@jvr.aphp.fr
Unit Hôpital Jean Verdier
Organization APHP
Collaborations
Funding
Funding status Mixed
Details Institut national contre le Cancer, ANRS, ARC
Governance of the database
Sponsor(s) or organisation(s) responsible DRCD ILE DE FRANCE, APHP
Organisation status Public
Additional contact
Main features
Type of database
Type of database Study databases
Study databases (details) Cohort study
Database recruitment is carried out by an intermediary A selection of health institutions and services
Database recruitment is carried out as part of an interventional study No
Additional information regarding sample selection. Prospective Inclusion cut-off date: April 2017 Number of required subjects: 1,200
Database objective
Main objective General objective: to describe the natural history of hepatocellular carcinoma (HCC) in alcoholic cirrhosis. Secondary objectives: - to establish a comparison with the national cohort - to establish a comparison with the national cohort of viral cirrhosis ANRS CO12 CirVir - to form an ancillary study database from biological resources taken at enrolment and afterwards annually as well as associated clinical data.
Inclusion criteria Adult patients with compensated and non-complicated alcoholic cirrhosis at the time of enrolment.
Population type
Age Adulthood (19 to 24 years)
Adulthood (25 to 44 years)
Adulthood (45 to 64 years)
Elderly (65 to 79 years)
Population covered Sick population
Gender Male
Woman
Geography area International
Detail of the geography area Multicentric cohort throughout France and Belgium (24 centres).
Data collection
Dates
Date of first collection (YYYY or MM/YYYY) 10/2010
Size of the database
Size of the database (number of individuals) < 500 individuals
Details of the number of individuals 350 (01/05/2013) 1200 (2017)
Data
Database activity Current data collection
Type of data collected Clinical data
Declarative data
Biological data
Clinical data (detail) Direct physical measures
Medical registration
Declarative data (detail) Paper self-questionnaire
Face to face interview
Biological data (detail) NFS, platelets; bilirubin, AST, ALT, alkaline phosphatase, gamma-glutamyl transferase; albumin and gammaglobulin; prothrombin time, INR; creatinine, glucose, total cholesterol, triglycerides; serum iron, ferritin and coefficient of transferrin saturation; alpha-fetoprotein, characterisation of HIV coinfection as appropriate, date and result of oesophageal endoscopy, date and result of last liver ultrasound
Presence of a biobank Yes
Contents of biobank Serum
Plasma
DNA
Details of biobank content Serum bank, plasma bank, DNA bank
Health parameters studied Health event/morbidity
Health event/mortality
Health care consumption and services
Care consumption (detail) Medical/paramedical consultation
Procedures
Data collection method Clinical examinations: handwritten Biological analysis: handwritten
Participant monitoring Yes
Details on monitoring of participants Follow-up duration: minimum 3 years
Links to administrative sources No
Promotion and access
Promotion
Access
Terms of data access (charter for data provision, format of data, availability delay) Data may be used by academic teams. Data may be used by industrial teams. Following review of projects by the scientific council and agreement thereof.
Access to aggregated data Access on specific project only
Access to individual data Access on specific project only

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