ITMO public health
Last update : 11/02/2015 | Version : 3 | ID : 8203
| General | |
| Identification | |
| Detailed name | Cohort of HIV/HCV Coinfected Patients with First Cirrhosis Decompensation or Hepatocellular Carcinoma |
| Sign or acronym | PRETHEVIC |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | CNIL |
| General Aspects | |
| Medical area |
Cancer research Gastroenterology et hepatology Infectious diseases |
| Keywords | HIV/HCV coinfection, prognostic survival factors, registration, transplant list, hepatic transplantation, liver transplantation |
| Scientific investigator(s) (Contact) | |
| Name of the director | Duclos Vallée |
| Surname | Jean-Charles |
| Address | 12-14 avenue Paul Vaillant Couturier 94800 Villejuif |
| Phone | +33 (0)1 45 59 30 28 |
| jean-charles.duclos-vallee@pbr.aphp.fr | |
| Unit | Centre Hépato-biliaire Paul Brousse |
| Organization | Hôpital Paul |
| Collaborations | |
| Funding | |
| Funding status |
Public |
| Details | -AP-HP - ANRS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Centre hépato-biliaire Paul Brousse |
| 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 |
| Database objective | |
| Main objective | The main objective is to describe progress and treatment for HIV/HCV coinfected individuals with first hepatic decompensation (HCC): frequency, type of hepatic decompensation, rate of liver function deterioration, percentage of patients that are included on the transplant list, percentage of patients that have had grafts, etc. |
| Inclusion criteria |
- Aged 18 or over;
- Positive HIV serology; - Positive HCV serology; - Hepatic cirrhosis (histology/clinical– biological – radiological evidence –non-invasive methods) - first episode of decompensation (ascites/gastrointestinal bleeding/hepatorenal syndrome/hepatic encephalopathy/ non-obstructive jaundice) OR HCC diagnosed less than a year ago. |
| 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 |
National |
| Detail of the geography area | 53 sites throughout France (île de France, Rennes, Brest, Nantes, Tourcoing, Nancy, Besançon, Dijon, Lyon, Grenoble, Aix, Nice, Marseilles, Montpellier, Toulouse, Bordeaux, Limoges and Tours). |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 05/2009 |
| Date of last collection (YYYY or MM/YYYY) | 05/2014 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 100 |
| Data | |
| Database activity |
Data collection completed |
| Type of data collected |
Clinical data Paraclinical data Biological data |
| Clinical data (detail) |
Direct physical measures |
| Details of collected clinical data | Liver transplant. |
| Paraclinical data (detail) | Radiology and endoscopy. |
| Biological data (detail) | Anti-HVC antibodies, seropositive HIV. |
| Presence of a biobank |
Yes |
| Contents of biobank |
Cell lines |
| Details of biobank content | Cell lines. |
| Health parameters studied |
Health event/morbidity Health event/mortality Health care consumption and services |
| Care consumption (detail) |
Hospitalization |
| Procedures | |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Quarterly collection of clinical, biological, radiological and endoscopic data will be carried out. A biobank will be established at baseline and then once a year. |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://tinyurl.com/PUBMED-PRETHEVIC |
| Description | Liste des publications dans Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Contact the scientist in charge. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
| ABOUT | CATALOG | RESOURCES | USEFUL LINKS |
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