ITMO public health
Last update : 05/26/2014 | Version : 1 | ID : 8933
| General | |
| Identification | |
| Detailed name | Longitudinal prospectice study on hepatocellular carcinoma in alcoholic or HCV-related cirrhotic patients |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL n°1254760, labelled Biological Resources Center (GH PSSD) |
| General Aspects | |
| Medical area |
Infectious diseases |
| Health determinants |
Addictions |
| Keywords | Alcoholic cirrhosis, Hepatitis C virus, hepatocellular carcinoma, α-fetoprotein, liver biopsy, liver ultrasonography., HCV, HCC, genetics |
| Scientific investigator(s) (Contact) | |
| Name of the director | Nahon |
| Surname | Pierre |
| Address | Service d’Hépato-gastroentérologie, Hôpital Jean Verdier, 93140 Bondy, France. |
| Phone | +33 (0)1 48 02 62 80 |
| pierre.nahon@jvr.aphp.fr | |
| Unit |
Inserm, UMR-1162, Génomique fonctionnelle des tumeurs solides, 27 rue Juliette Dodu 75010 Paris, France Service d’Hépato-gastroentérologie, Hôpital Jean Verdier, 93140 Bondy, France. |
| Organization | AP-HP |
| Collaborations | |
| Funding | |
| Funding status |
Mixed |
| Details | University Paris 13, Association Française pour l’Etude du Foie (AFEF), Institut de recherches scientifiques sur les boissons (IREB), AP-HP. |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | INSERM |
| Organisation status |
Public |
| Sponsor(s) or organisation(s) responsible | AP-HP |
| 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. | Participation in the study was offered to all new patients who were consecutively referred to the liver unit of the Jean Verdier Hospital for diagnosis and management of cirrhosis since January 1999 and who fulfilled the inclusion criteria. |
| Database objective | |
| Main objective | The present database aims at enabling the study of the relationship between alcoholic cirrhosis or HCV-related cirrhosis and hepatocellular carcinoma while providing information on the clinical follow-up of patients. The database is complemented by biological samples : cryopreserved DNA and serum of patients included in the study, in order to enable genetic and molecular analysis in cirrhotic patients. |
| Inclusion criteria |
- histologically proven cirrhosis, whatever the time of biopsy; - no infection from the human immunodeficiency virus or hepatitis B virus; - no evidence of HCC at the time of inclusion as judged by negative ultrasonographic findings, and a serum α-fetoprotein (AFP) level of inferior to 50 ng/ml; - residence in France; - acceptance of a regular follow-up and periodical HCC screening; - Caucasian origin; - written informed consent for the use of frozen DNA. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) Elderly (65 to 79 years) Great age (80 years and more) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
Regional |
| French regions covered by the database |
Île-de-France |
| Detail of the geography area | Jean Verdier Hospital, Bondy, France |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 01/1999 |
| Size of the database | |
| Size of the database (number of individuals) |
[500-1000[ individuals |
| Details of the number of individuals | 532: - 253 HCV-related cirrhotic patients - 279 alcoholic cirrhotic patients |
| Data | |
| Database activity |
Current data collection |
| Type of data collected |
Clinical data Declarative data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures Medical registration |
| Details of collected clinical data | Socio-demographic characteristics, Body Mass Index, past history of diabetes mellitus. |
| Declarative data (detail) |
Face to face interview |
| Details of collected declarative data | Socio-demographic characteristics, Body Mass Index, past history of diabetes mellitus. |
| Paraclinical data (detail) | presence of ascites or hepatic encephalopathy, liver biopsy for all patients, virological data for HCV-infected patients. |
| Biological data (detail) | Serum bilirubin, albumin and prothrombin levels, serum alanine-aminotransferase activity, and serum aspartate-aminotransferase activity. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Whole blood Serum Tissues DNA |
| Details of biobank content | Cryopreserved DNA. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization Medical/paramedical consultation Medicines consumption |
| Procedures | |
| Quality procedure(s) used | Labelled Biological Resources Center (CRB) GH PSSD |
| Participant monitoring |
Yes |
| Details on monitoring of participants | All patients were followed-up and evaluated after their inclusion at a minimum of 6-month intervals by physical examination, liver ultrasonography, and serum AFP level assessment, and in case HCC was suspected: computed tomodensitometry, and/or magnetic-resonance imaging and/or a guided liver biopsy were performed according to the recommendations of the Barcelona Conference. HCC was diagnosed according to one of the following criteria: histological evidence or convergent demonstration of a focal lesion superior to 2 cm in size, and arterial hypervascularization, as assessed by two different imaging techniques, or a combination of one imaging technique that showed this morphological aspect plus a serum AFP level superior or equal to 400 ng/ml. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.cghjournal.org/article/S1542-3565%2804%2900718-9/fulltext |
| Link to the document | http://cancerres.aacrjournals.org/content/66/5/2844.long |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/17413295 |
| Link to the document | http://www.cghjournal.org/article/S1542-3565%2806%2901200-6/fulltext |
| Link to the document | http://www.gastrojournal.org/article/S0016-5085%2807%2901918-X/fulltext |
| Link to the document | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2683997/ |
| Link to the document | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2744164/ |
| Link to the document | http://onlinelibrary.wiley.com/doi/10.1002/hep.23187/full |
| Link to the document | http://cebp.aacrjournals.org/content/20/7/1439.long |
| Link to the document | http://europepmc.org/abstract/MED/21907168/reload |
| Link to the document | http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3527286/ |
| Link to the document | http://www.sciencedirect.com/science/article/pii/S0168827812007763 |
| Link to the document | http://www.jhep-elsevier.com/article/S0168-8278%2814%2900264-5/abstract |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | For more information, contact the scientific manager. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
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