ITMO public health
Last update : 06/02/2015 | Version : 2 | ID : 73102
| General | |
| Identification | |
| Detailed name | Prospective cohort involving patients with viral cirrhosis B and C |
| Sign or acronym | ANRS CO12 CIRVIR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CPP : PC/AP 11-2005 (15.06.2012), CNIL : 90.54.63 (19.01.2006), CCTIRS : 05.394 (01.09.2005) |
| General Aspects | |
| Medical area |
Gastroenterology et hepatology |
| Health determinants |
Lifestyle and behavior |
| Keywords | Cirrhosis related HCV and/or HBV, HCC, predictive factors, prognostic factors |
| Scientific investigator(s) (Contact) | |
| Name of the director | Nahon |
| Surname | Pierre |
| Address |
Service d'Hépatologie, Hôpital Jean verdier, Bondy et Faculté Paris 13 - UFR SMBH, Bobigny, France UMR-1162, Génomique fonctionnelle des tumeurs solides, 27 rue Juliette Dodu 75010 Paris, France |
| Phone | +33148026299 |
| pierre.nahon@aphp.fr | |
| Unit | Service d’Hépatologie, Hôpital Jean Verdier |
| Organization | APHP-Inserm |
| Name of the director | Roudot-thoraval |
| Surname | Françoise |
| Address |
51, Boulevard du Maréchal de Lattre de Tassigny 94010 Créteil |
| francoise.roudot-thoraval@hmr.aphp.fr | |
| Unit | Service de santé publique, Hôpital Henri Mondor |
| Organization | APHP |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | Agence Nationale de Recherche sur le Sida et les hépatites Virales (ANRS - agence autonome de l'Inserm) |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Agence Nationale de Recherches sur le SIDA et les Hépatites Virales (ANRS) Public |
| 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 - Closing date for inclusion not determined |
| Database objective | |
| Main objective | Description of the natural history of HBV and/or HCV compensated cirrhosis. |
| Inclusion criteria |
1. Presence of a histologically proven cirrhosis (metavir F4 or established cirrhosis)
2. No prior episode, not on the day of inclusion, decompensation or CHC 3. Presence of a laboratory evidence of infection with the hepatitis B and/or hepatitis C virus Note: HIV coinfections are eligible. |
| 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 |
National |
| Detail of the geography area | 38 centers in France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 03/2006 |
| Size of the database | |
| Size of the database (number of individuals) |
[1000-10 000[ individuals |
| Details of the number of individuals | 2000 |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Medical registration |
| Biological data (detail) | CBC-platelets, TP, factor V, normal liver chemistry (ASAT, ALAT, PA, GGT), total bilirubin, albumin, alpha fetoprotein |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma DNA |
| Details of biobank content | Serum bank, plasma bank, cell bank |
| Health parameters studied |
Health event/morbidity Health event/mortality |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Half-year follow-up (according to HAS recommendations) in terms of clinical examination, biological balance and imagery examination |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.hal.inserm.fr/CO12_CIRVIR |
| Description | List of publications in HAL |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=CO12+Cirvir |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) |
Methods of distribution: BEH
Request placed with the Investigator-coordinator |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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