跳至主要内容
临床试验/NCT01164436
NCT01164436已完成不适用

French Cohort of HIV Associated Lymphomas

ANRS, Emerging Infectious Diseases1 个研究点 分布在 1 个国家目标入组 205 人开始时间: 2008年6月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
205
试验地点
1
主要终点
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

研究概览

简要总结

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).

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

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

时间窗: 5 year

次要结局

  • Levels of EBV in tumors of HIV patients with NHL or HL(5 year)
  • Survival rate in HIV patients with NHL or HL(5 year)
  • Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL(5 year)
  • Progression-free survival rate in HIV patients with NHL or HL(5 year)

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验

Cohort of HIV Associated Lymphomas | 临床试验