Cohort of HIV Associated Lymphomas
ANRS CO16
French Cohort of HIV Associated Lymphomas
1 other identifier
observational
205
1 country
1
Brief Summary
The incidence of lymphomas is increased among HIV infected patients. In 70 % of cases, those are Non Hodgkin's lymphomas (NHL) and Hodgkin lymphomas (HL) in 30% of cases. In France, their incidence is estimated to 100 cases per year (data from the "Base de données Hospitalière Française sur l'Infection à VIH" (FHDH)). The main mechanisms involved in lymphomagenesis are immune dysfunction, involvement of oncogenic viruses (Epstein-Barr (EBV) and HHV8) and molecular oncogenic events. A better understanding of these different pathways, give the possibility to design specific treatments. The treatment of these lymphomas is not standardized. A prospective study of patients with HIV associated lymphoid malignancies is an innovating tool to answer epidemiological, physiopathological and therapeutic questions. We propose a prospective multicentric study of these patients. The main objectives of this prospective study are to:
- evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
- perform an observational study of the treatment and outcome of these patients out of the context of clinical trials,
- study the differentiation and activation of B-cell populations,
- better understand the role of specific T cell responses in the control of EBV infection,
- allow other biological studies from the ANRS group " Lymphome et VIH ". The recruitment of 40 cases per year is expected. The length of inclusions is 7 years. The follow-up will be of 2 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collections (Y.Taoufik, S Prevot\* ). To better understand the EBV infection and lymphomagenesis in HIV infection, we propose to follow the viral load and the molecular characteristics of EBV in PBMC, plasma and tumour (P.Morand\* , V.Boyer\* ), to investigate the EBV-T cell responses (G.Carcelain) and the presence and reactivation of EBV in peripheral B cells (C.Amiel\* , JC Nicolas) and in tumoral samples (M.Raphael\* , I.Joab\* ). The other mechanisms of lymphomagenesis in HIV infection will be studied by the analysis of the sub-populations of B-cells in terms of activation and differentiation (Y.Taoufik) and by the characterization of MSI tumours (A.Duval).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2008
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2008
CompletedFirst Submitted
Initial submission to the registry
December 22, 2009
CompletedFirst Posted
Study publicly available on registry
July 16, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedNovember 6, 2017
October 1, 2017
7 years
December 22, 2009
October 31, 2017
Conditions
Outcome Measures
Primary Outcomes (1)
Correlation between EBV viral load and plasma HIV RNA viral load and CD4 cell count in HIV-infected patients with lymphomas (LNH or LH) at the time of lymphoma diagnosis
5 year
Secondary Outcomes (4)
Survival rate in HIV patients with NHL or HL
5 year
Progression-free survival rate in HIV patients with NHL or HL
5 year
Levels of EBV in tumors of HIV patients with NHL or HL
5 year
Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL
5 year
Eligibility Criteria
The recruitment of 80 cases per year is expected. The length of inclusions is 5 years. The follow-up will be of 5 years. Clinical, pathological and biological data at diagnosis and during follow-up will be collected. This will allow characterizing the lymphoma, the HIV infection, the antitumoral treatments and the outcome of lymphoma. Biological samples will be centralized to collect cell, DNA, RNA, plasma, serum and tumour collection.
You may qualify if:
- Male and female patients over 18 years of age
- patients with HIV-1 or 2 infection
- with Non Hodgkin's lymphomas (NHL) or Hodgkin lymphomas (HL) in the diagnosis or in relapse
- sign an informed consent
You may not qualify if:
- patients who suffered from acute leukemia
- patients treated for lymphoïd blood disease
- Patients whose lymphomas treatment was stopped for less than 3 months
- unaffiliated to the social healthy security french system
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- ANRS, Emerging Infectious Diseaseslead
- Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud Francecollaborator
- Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris Francecollaborator
- University Hospital, Grenoblecollaborator
- Dr Irène Joab Hôpital Paul Brousse Villejuif Francecollaborator
- Dr Alex Duval Fondation Jean Dausset CEPHcollaborator
- Hopital Antoine Beclerecollaborator
Study Sites (1)
BESSON
Paris, France
Related Publications (1)
Lievin R, Maillard A, Hendel-Chavez H, Krzysiek R, Lancar R, Algarte-Genin M, Costagliola D, Assoumou L, Taoufik Y, Besson C. Immune reconstitution and evolution of B-cell-stimulating cytokines after R-CHOP therapy for HIV-associated DLBCL. Blood Adv. 2024 Dec 10;8(23):6017-6027. doi: 10.1182/bloodadvances.2024014116.
PMID: 39348664DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline BESSON
Service Hématologie Immunologie Biologie, Hopital Bicetre
- PRINCIPAL INVESTIGATOR
Gilles Pialoux, PH
Hôpital Tenon Paris
- PRINCIPAL INVESTIGATOR
Marie Caroline Meyonas, PH
Hôpital St Antoine Paris
- PRINCIPAL INVESTIGATOR
Christine Katlama, PH
Hôpital Pitiè Salpétrière
- PRINCIPAL INVESTIGATOR
Jean Gabarre, MD
Hôpital Pitiè Salpétrière Paris
- PRINCIPAL INVESTIGATOR
Dominique Salmon, PH
Hôpital Cochin PARIS
- PRINCIPAL INVESTIGATOR
François Dreyfus, PH
Hôpital Cochin Paris
- PRINCIPAL INVESTIGATOR
Jean Paul Viard, PH
Hotel Dieu PARIS
- PRINCIPAL INVESTIGATOR
Alain Devidas, PH
Corbeil Essone 91
- PRINCIPAL INVESTIGATOR
Emma Goldschmidt, MD
Villejuif 94
- PRINCIPAL INVESTIGATOR
Cecile Goujard, MD
Hôpital Bicêtre 94
- PRINCIPAL INVESTIGATOR
Laurent Blum, MD
Pointoise 95
- PRINCIPAL INVESTIGATOR
François Boué, PH
Clamart 92
- PRINCIPAL INVESTIGATOR
Eric Rosenthal, MD
Nice 06
- PRINCIPAL INVESTIGATOR
Christine Burty, MD
Vandoeuvre les Nancy 54
- PRINCIPAL INVESTIGATOR
Jean Marie Lang, PH
Strasbourg 67
- PRINCIPAL INVESTIGATOR
Renaud Verdon, PH
Caen 14
- PRINCIPAL INVESTIGATOR
Yazdan Yazdanpanah, PH
Tourcoing 59
- PRINCIPAL INVESTIGATOR
Christine Drobacheff, MD
Besancon 25
- PRINCIPAL INVESTIGATOR
Bruno Marchou, PH
Toulouse 31
- PRINCIPAL INVESTIGATOR
Corinne Couteau, MD
Toulouse 31
- PRINCIPAL INVESTIGATOR
Philippe Morlat, PH
Bordeaux 33
- PRINCIPAL INVESTIGATOR
Christian Trepo, PH
Lyon 69
- PRINCIPAL INVESTIGATOR
Hervé Ghesquières, PH
Lyon 69
- PRINCIPAL INVESTIGATOR
Régis Costellos, PH
Marseille
- PRINCIPAL INVESTIGATOR
Bertrand Coiffier, Ph
Pierre Bénite
- PRINCIPAL INVESTIGATOR
Claude Beuscart, MD
St Brieuc 22
- PRINCIPAL INVESTIGATOR
Philippe Perre, MD
La Roche Sur Yon 85
- PRINCIPAL INVESTIGATOR
Patrice Poubeau, MD
St Pierre 97
- PRINCIPAL INVESTIGATOR
François Raffi, PH
Nantes 44
- PRINCIPAL INVESTIGATOR
Frédéric Lucht, PH
St Etienne 42
- PRINCIPAL INVESTIGATOR
Nicolas Mounier, PH
Nice 06
- PRINCIPAL INVESTIGATOR
Cédric Arvieux, PH
Rennes 35
- PRINCIPAL INVESTIGATOR
Serge Herson, PH
Pitié Salpétrière Paris
- PRINCIPAL INVESTIGATOR
Jean François Bergmann, PH
Lariboisière Paris
- PRINCIPAL INVESTIGATOR
André Cabié, PH
Fort de France 97( Martinique)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER GOV
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 22, 2009
First Posted
July 16, 2010
Study Start
June 1, 2008
Primary Completion
June 1, 2015
Study Completion
June 1, 2017
Last Updated
November 6, 2017
Record last verified: 2017-10