Cohort of HIV Associated Lymphomas (ANRS CO16)

French Cohort of HIV Associated Lymphomas

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).

Study Overview

• Status: Completed
• Conditions: HIV Infection

• Study Type: Observational
• Enrollment (Actual): 205

Contacts and Locations

Study Locations

• France
  • Paris, France
    • BESSON

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	measurement of EBV using in situ hybridization applied to paraffin sections	5 year
Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL	measurement of concentrations of IL-6, IL-10, BAFF in plasma	5 year

Collaborators and Investigators

• Sponsor: ANRS, Emerging Infectious Diseases
• Collaborators: University Hospital, Grenoble; Hopital Antoine Beclere; Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France; Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France; Dr Irène Joab Hôpital Paul Brousse Villejuif France; Dr Alex Duval Fondation Jean Dausset CEPH
• Investigators: Principal Investigator: Caroline BESSON, Service Hématologie Immunologie Biologie, Hopital Bicetre; Principal Investigator: Gilles Pialoux, PH, Hopital Tenon Paris; Principal Investigator: Marie Caroline Meyonas, PH, Hôpital St Antoine Paris; Principal Investigator: Christine Katlama, PH, Hopital Pitie Salpetriere; 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 Benite; 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 record dates

Study Major Dates

• Study Start: June 1, 2008
• Primary Completion (ACTUAL): June 1, 2015
• Study Completion (ACTUAL): June 1, 2017

Study Registration Dates

• First Submitted: December 22, 2009
• First Submitted That Met QC Criteria: July 15, 2010
• First Posted (ESTIMATE): July 16, 2010

Study Record Updates

• Last Update Posted (ACTUAL): November 6, 2017
• Last Update Submitted That Met QC Criteria: October 31, 2017
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Lymphoma, Non-Hodgkin; Lymphoma; Lymphoma, B-Cell; Lymphoma, AIDS-Related
• Other Study ID Numbers: 2007-AO0258-45