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