Cohort of HIV Associated Lymphomas (ANRSCO16)

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Sponsor:
Collaborators:
Collect cell and immune study
Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France
Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France
Virology study
Dr Patrice Morand et Veronique Boyer CHU Grenoble France Dr Corinne Amiel Hopital Tenon Paris France
Dr Irène Joab Hôpital Paul Brousse Villejuif France
Anatomo-pathologie
Pr Sophie Prévot Hôpital Béclère France
Génétique des tumeurs
Dr Alex Duval Fondation Jean Dausset CEPH
Information provided by (Responsible Party):
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier:
NCT01164436
First received: December 22, 2009
Last updated: July 22, 2014
Last verified: July 2014
  Purpose

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 80 cases per year is expected. The length of inclusions is 7 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 collections (Y.Taoufik, M.Raphael* ). 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).


Condition
HIV Infection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: French Cohort of HIV Associated Lymphomas

Resource links provided by NLM:


Further study details as provided by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS):

Primary Outcome Measures:
  • The main objectives of this prospective study are to: evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV [ Designated as safety issue: No ]

Estimated Enrollment: 400
Study Start Date: June 2008
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164436

Contacts
Contact: Dominique COSTAGLIOLA, Methodologie 0142164272 dcostagliola@ccde.chups.jussieu.fr
Contact: Michèle GENIN, project manager mgenin@ccde.chups.jussieu.fr

Locations
France
BESSON Recruiting
Paris, France
Sponsors and Collaborators
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Collect cell and immune study
Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France
Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France
Virology study
Dr Patrice Morand et Veronique Boyer CHU Grenoble France Dr Corinne Amiel Hopital Tenon Paris France
Dr Irène Joab Hôpital Paul Brousse Villejuif France
Anatomo-pathologie
Pr Sophie Prévot Hôpital Béclère France
Génétique des tumeurs
Dr Alex Duval Fondation Jean Dausset CEPH
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)
  More Information

Additional Information:
No publications provided

Responsible Party: French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
ClinicalTrials.gov Identifier: NCT01164436     History of Changes
Other Study ID Numbers: 2007-AO0258-45
Study First Received: December 22, 2009
Last Updated: July 22, 2014
Health Authority: France: ANSM The French National Agency for Medicines and Health Products Safety

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lymphoma
Lymphoma, AIDS-Related
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Lymphoma, B-Cell
Lymphoma, Non-Hodgkin

ClinicalTrials.gov processed this record on July 26, 2014