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Completed

NCT Number: NCT01164436

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).

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

    Time frame: 5 year

Secondary outcomes

  1. Survival rate in HIV patients with NHL or HL

    Time frame: 5 year

  2. Progression-free survival rate in HIV patients with NHL or HL

    Time frame: 5 year

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

ANRS, Emerging Infectious Diseases

Other Gov

Collaborators

  • Dr Alex Duval Fondation Jean Dausset CEPH
  • Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France
  • Dr Irène Joab Hôpital Paul Brousse Villejuif France
  • Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France
  • Hopital Antoine Beclere
  • University Hospital, Grenoble

Registry information

Official study title

French Cohort of HIV Associated Lymphomas

Acronym: ANRS CO16

Important dates

Study start
2008
Primary completion
2015
Study completion
2017
First posted
Jul 16, 2010
Registry last updated
Nov 6, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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