Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

Cohort of HIV Associated Lymphomas (ANRS CO16)

This study is ongoing, but not recruiting participants.
Sponsor:
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
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: September 29, 2016
Last verified: September 2016

December 22, 2009
September 29, 2016
June 2008
June 2015   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
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 ]
Complete list of historical versions of study NCT01164436 on ClinicalTrials.gov Archive Site
  • Survival rate in HIV patients with NHL or HL [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Progression-free survival rate in HIV patients with NHL or HL [ Time Frame: 5 year ] [ Designated as safety issue: No ]
  • Levels of EBV in tumors of HIV patients with NHL or HL [ Time Frame: 5 year ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    measurement of concentrations of IL-6, IL-10, BAFF in plasma
Not Provided
Not Provided
Not Provided
 
Cohort of HIV Associated Lymphomas
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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Not Provided
Non-Probability Sample
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.
HIV Infection
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
400
December 2017
June 2015   (final data collection date for primary outcome measure)

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
Both
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
France
 
NCT01164436
2007-AO0258-45
No
Not Provided
Not Provided
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
  • 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
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)
French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
September 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP