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Cohort of HIV Associated Lymphomas

French Cohort of HIV Associated Lymphomas

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01164436
Acronym
ANRS CO16
Enrollment
205
Registered
2010-07-16
Start date
2008-06-30
Completion date
2017-06-30
Last updated
2017-11-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

HIV Infection

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 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).

Interventions

None listed

Sponsors

Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France
CollaboratorUNKNOWN
Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France
CollaboratorUNKNOWN
University Hospital, Grenoble
CollaboratorOTHER
Dr Irène Joab Hôpital Paul Brousse Villejuif France
CollaboratorUNKNOWN
Dr Alex Duval Fondation Jean Dausset CEPH
CollaboratorUNKNOWN
Hopital Antoine Beclere
CollaboratorOTHER
ANRS, Emerging Infectious Diseases
Lead SponsorOTHER_GOV

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 diagnosis5 year

Secondary

MeasureTime frameDescription
Survival rate in HIV patients with NHL or HL5 year
Progression-free survival rate in HIV patients with NHL or HL5 year
Levels of EBV in tumors of HIV patients with NHL or HL5 yearmeasurement of EBV using in situ hybridization applied to paraffin sections
Levels of B cell activating cytokines in plasma of HIV patients with NHL or HL5 yearmeasurement of concentrations of IL-6, IL-10, BAFF in plasma

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026