Cohort of HIV Associated Lymphomas (ANRS CO16)

Tracking Information
First Submitted Date	December 22, 2009
First Posted Date	July 16, 2010
Last Update Posted Date	November 6, 2017
Study Start Date	June 2008
Actual Primary Completion Date	June 2015 (Final data collection date for primary outcome measure)
Current Primary Outcome Measures; (submitted: September 29, 2015)	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 [ Time Frame: 5 year ]
Original Primary Outcome Measures; (submitted: July 15, 2010)	The main objectives of this prospective study are to: evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV
Change History	Complete list of historical versions of study NCT01164436 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures; (submitted: September 29, 2015)	Survival rate in HIV patients with NHL or HL [ Time Frame: 5 year ]; Progression-free survival rate in HIV patients with NHL or HL [ Time Frame: 5 year ]; Levels of EBV in tumors of HIV patients with NHL or HL [ Time Frame: 5 year ]measurement of EBV using in situ hybridization applied to paraffin sections; Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL [ Time Frame: 5 year ]measurement of concentrations of IL-6, IL-10, BAFF in plasma
Original Secondary Outcome Measures	Not Provided
Current Other Outcome Measures	Not Provided
Original Other Outcome Measures	Not Provided
Descriptive Information
Brief Title	Cohort of HIV Associated Lymphomas
Official Title	French Cohort of HIV Associated Lymphomas
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).
Detailed Description	Not Provided
Study Type	Observational
Study Design	Observational Model: Cohort; Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Not Provided
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.
Condition	HIV Infection
Intervention	Not Provided
Study Groups/Cohorts	Not Provided
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status	Completed
Actual Enrollment; (submitted: October 31, 2017)	205
Original Estimated Enrollment; (submitted: July 15, 2010)	400
Actual Study Completion Date	June 2017
Actual Primary Completion Date	June 2015 (Final data collection date for primary outcome measure)
Eligibility Criteria	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
Sex/Gender	Sexes Eligible for Study: All
Ages	18 Years to 65 Years (Adult, Older Adult)
Accepts Healthy Volunteers	No
Contacts	Contact information is only displayed when the study is recruiting subjects
Listed Location Countries	France
Removed Location Countries
Administrative Information
NCT Number	NCT01164436
Other Study ID Numbers	2007-AO0258-45
Has Data Monitoring Committee	No
U.S. FDA-regulated Product	Not Provided
IPD Sharing Statement	Not Provided
Responsible Party	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Study Sponsor	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collaborators	Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France; Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France; University Hospital, Grenoble; Dr Irène Joab Hôpital Paul Brousse Villejuif France; Dr Alex Duval Fondation Jean Dausset CEPH; Hopital Antoine Beclere
Investigators	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)
PRS Account	French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Verification Date	October 2017