ANRS CO16 LYMPHOVIR - Cohort of Patients with HIV Associated Lymphoma
Head :
Besson Caroline, SERVICE D'HÉMATOLOGIE, IMMUNOLOGIE BIOLOGIQUE (PR MARTINE RAPHAËL) HÔPITAL DE BICÊTRE 78, RUE DU GÉNÉRAL LECLERC, 94275 LE KREMLIN-BICÊTRE CÉDEX
Costagliola Dominique, INSERM U943 EPIDEMIOLOGIE, STRATÉGIES THÉRAPEUTIQUES ET VIROLOGIE CLINIQUES DANS L'INFECTION À VIH 56 BD V AURIOL, BP 335, 75625 PARIS CEDEX 13, FRANCE
Costagliola Dominique, INSERM U943 EPIDEMIOLOGIE, STRATÉGIES THÉRAPEUTIQUES ET VIROLOGIE CLINIQUES DANS L'INFECTION À VIH 56 BD V AURIOL, BP 335, 75625 PARIS CEDEX 13, FRANCE
Last update : 07/07/2015 | Version : 2 | ID : 60062
| General | |
| Identification | |
| Detailed name | Cohort of Patients with HIV Associated Lymphoma |
| Sign or acronym | ANRS CO16 LYMPHOVIR |
| CNIL registration number, number and date of CPP agreement, AFSSAPS (French Health Products Safety Agency) authorisation | Accord CNIL: 28/05/2007 |
| General Aspects | |
| Medical area |
Cancer research Cardiology Immunology Infectious diseases |
| Health determinants |
Genetic |
| Keywords | event-free survival, Health episodes, overall survival, quality of life |
| Scientific investigator(s) (Contact) | |
| Name of the director | Besson |
| Surname | Caroline |
| Address | 94275 LE KREMLIN-BICÊTRE |
| Phone | + 33 (0)1 45 21 20 16 |
| caroline.besson@bct.aphp.fr | |
| Unit | SERVICE D'HÉMATOLOGIE, IMMUNOLOGIE BIOLOGIQUE (PR MARTINE RAPHAËL) HÔPITAL DE BICÊTRE 78, RUE DU GÉNÉRAL LECLERC, 94275 LE KREMLIN-BICÊTRE CÉDEX |
| Organization | AP-HP |
| Name of the director | Costagliola |
| Surname | Dominique |
| Address | 75625 PARIS |
| Phone | + 33 (0)1 42 16 42 82 |
| dcostagliola@ccde.chups.jussieu.fr | |
| Unit | INSERM U943 EPIDEMIOLOGIE, STRATÉGIES THÉRAPEUTIQUES ET VIROLOGIE CLINIQUES DANS L'INFECTION À VIH 56 BD V AURIOL, BP 335, 75625 PARIS CEDEX 13, FRANCE |
| Organization | INSERM - Institut National de Santé et Recherche |
| Collaborations | |
| Participation in projects, networks and consortia |
Yes |
| Funding | |
| Funding status |
Public |
| Details | ANRS |
| Governance of the database | |
| Sponsor(s) or organisation(s) responsible | Agence Nationale de Recherches sur le Sida et les hépatites virales (ANRS) |
| 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: 01/07/2015 |
| Database objective | |
| Main objective | General objective: to better understand the physiopathology of non-Hodgkin lymphoma (NHL) and Hodgkin lymphoma (HL) associated with HIV by studying, on the one hand, interaction between Epstein-Barr virus (EBV) and HIV infection from a virological and immunological viewpoint and, on the other hand, the role of chronic antigen stimulation. Secondary objectives: - Clinical and histological characterisation of lymphoma; - to undertake an observational study on the treatment and outcome for these patients in terms of antiretroviral therapy; - to create a forum concerning therapeutic care for these patients; - To enable "Lymphoma and HIV" studies developed by the ANRS group: (1) Clinical: (a) To define prognostic factors for unfavourable progression of NHL and HL (b) To develop target treatment consensus according to histology and clinical presentation for patients included in the cohort (2) Anatomical and clinical: to characterise lymphoproliferations and investigate the presence and reactivation of EBV in these tumours (3) Immunological: to study anti-EBV immune T cell response and their role in the pathophysiology of EBV-related lymphomas, to characterise the activation status of circulating B cells (4) Virological: to quantify viral load and anti-EBV antibody titres, to genotype EBV variants for HL patients, to study the replication of EBV in B lymphocyte memory, to investigate the interaction of TGF-induced EBV replication and cell survival in tumour cells infected by EBV (5) Molecular: to study the "microsatellite instability" (MSI) phenotype of these tumours. |
| Inclusion criteria | - Adults (18 years old); - infected by HIV-1 or HIV-2; - NHL or HL diagnosis or relapse (including cerebral lymphoma); - who have given clear and written consent. |
| Population type | |
| Age |
Adulthood (19 to 24 years) Adulthood (25 to 44 years) Adulthood (45 to 64 years) |
| Population covered |
Sick population |
| Gender |
Male Woman |
| Geography area |
National |
| Detail of the geography area | Multicentric cohort throughout France (35 centres) |
| Data collection | |
| Dates | |
| Date of first collection (YYYY or MM/YYYY) | 07/2008 |
| Date of last collection (YYYY or MM/YYYY) | 07/2018 |
| Size of the database | |
| Size of the database (number of individuals) |
< 500 individuals |
| Details of the number of individuals | 150 |
| 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 |
| Declarative data (detail) |
Paper self-questionnaire |
| Paraclinical data (detail) | Imaging |
| Biological data (detail) | Type of samples taken: whole blood (60 ml), saliva, sample for lymphoma diagnosis |
| Presence of a biobank |
Yes |
| Contents of biobank |
Serum Plasma Cell lines DNA DNAc/RNAm |
| Details of biobank content | Serum bank, plasma bank, DNA bank, cell bank, RNA bank |
| Health parameters studied |
Health event/morbidity Health event/mortality Quality of life/health perception |
| Procedures | |
| Data collection method | Self-administered questionnaire: input from a paper questionnaire (manual input) Clinical Examination: handwritten (manual input) with double data entry Biological analysis: handwritten (manual input) with double data entry |
| Participant monitoring |
Yes |
| Details on monitoring of participants | Follow-up duration: 5 years |
| Links to administrative sources |
No |
| Promotion and access | |
| Promotion | |
| Link to the document | http://www.ncbi.nlm.nih.gov/pubmed/?term=ANRS+CO16+OR+LYMPHOVIR |
| Description | List of publications in Pubmed |
| Access | |
| Terms of data access (charter for data provision, format of data, availability delay) | Data may be used by academic teams Access to all or part of the study database will be specified by the scientific council and subject to the agreement of the sponsor. Data may not be used by industrial teams. |
| Access to aggregated data |
Access on specific project only |
| Access to individual data |
Access on specific project only |
