Clinical Trial: Cohort of HIV Associated Lymphomas

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Observational

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 coll

Detailed Summary:
Sponsor: French National Institute for Health and Medical Research-French National Agency for Research on AID

Current Primary Outcome: 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: The main objectives of this prospective study are to: evaluate the incidence, characterise clinically and histologically NHL and HL cases associated to HIV

Current Secondary Outcome:

  • 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:

Information By: French National Institute for Health and Medical Research-French National Agency for Research on AID

Dates:
Date Received: December 22, 2009
Date Started: June 2008
Date Completion: December 2017
Last Updated: September 29, 2016
Last Verified: September 2016