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Cohort of HIV Associated Lymphomas

NCT ID: NCT01164436

Last Updated: 2017-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

205 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-06-30

Study Completion Date

2017-06-30

Brief Summary

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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).

Detailed Description

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Conditions

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HIV Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dr Yassine Taoufik Dr Houria Chavez Hôpital Bicêtre CIB Paris Sud France

UNKNOWN

Sponsor Role collaborator

Dr Guislaine Garcelain Hôpital Pitié Slapétrière Paris France

UNKNOWN

Sponsor Role collaborator

University Hospital, Grenoble

OTHER

Sponsor Role collaborator

Dr Irène Joab Hôpital Paul Brousse Villejuif France

UNKNOWN

Sponsor Role collaborator

Dr Alex Duval Fondation Jean Dausset CEPH

UNKNOWN

Sponsor Role collaborator

Hopital Antoine Beclere

OTHER

Sponsor Role collaborator

ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Caroline BESSON

Role: PRINCIPAL_INVESTIGATOR

Service Hématologie Immunologie Biologie, Hopital Bicetre

Gilles Pialoux, PH

Role: PRINCIPAL_INVESTIGATOR

Hôpital Tenon Paris

Marie Caroline Meyonas, PH

Role: PRINCIPAL_INVESTIGATOR

Hôpital St Antoine Paris

Christine Katlama, PH

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitiè Salpétrière

Jean Gabarre, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Pitiè Salpétrière Paris

Dominique Salmon, PH

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cochin PARIS

François Dreyfus, PH

Role: PRINCIPAL_INVESTIGATOR

Hôpital Cochin Paris

Jean Paul Viard, PH

Role: PRINCIPAL_INVESTIGATOR

Hotel Dieu PARIS

Alain Devidas, PH

Role: PRINCIPAL_INVESTIGATOR

Corbeil Essone 91

Emma Goldschmidt, MD

Role: PRINCIPAL_INVESTIGATOR

Villejuif 94

Cecile Goujard, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Bicêtre 94

Laurent Blum, MD

Role: PRINCIPAL_INVESTIGATOR

Pointoise 95

François Boué, PH

Role: PRINCIPAL_INVESTIGATOR

Clamart 92

Eric Rosenthal, MD

Role: PRINCIPAL_INVESTIGATOR

Nice 06

Christine Burty, MD

Role: PRINCIPAL_INVESTIGATOR

Vandoeuvre les Nancy 54

Jean Marie Lang, PH

Role: PRINCIPAL_INVESTIGATOR

Strasbourg 67

Renaud Verdon, PH

Role: PRINCIPAL_INVESTIGATOR

Caen 14

Yazdan Yazdanpanah, PH

Role: PRINCIPAL_INVESTIGATOR

Tourcoing 59

Christine Drobacheff, MD

Role: PRINCIPAL_INVESTIGATOR

Besancon 25

Bruno Marchou, PH

Role: PRINCIPAL_INVESTIGATOR

Toulouse 31

Corinne Couteau, MD

Role: PRINCIPAL_INVESTIGATOR

Toulouse 31

Philippe Morlat, PH

Role: PRINCIPAL_INVESTIGATOR

Bordeaux 33

Christian Trepo, PH

Role: PRINCIPAL_INVESTIGATOR

Lyon 69

Hervé Ghesquières, PH

Role: PRINCIPAL_INVESTIGATOR

Lyon 69

Régis Costellos, PH

Role: PRINCIPAL_INVESTIGATOR

Marseille

Bertrand Coiffier, Ph

Role: PRINCIPAL_INVESTIGATOR

Pierre Bénite

Claude Beuscart, MD

Role: PRINCIPAL_INVESTIGATOR

St Brieuc 22

Philippe Perre, MD

Role: PRINCIPAL_INVESTIGATOR

La Roche Sur Yon 85

Patrice Poubeau, MD

Role: PRINCIPAL_INVESTIGATOR

St Pierre 97

François Raffi, PH

Role: PRINCIPAL_INVESTIGATOR

Nantes 44

Frédéric Lucht, PH

Role: PRINCIPAL_INVESTIGATOR

St Etienne 42

Nicolas Mounier, PH

Role: PRINCIPAL_INVESTIGATOR

Nice 06

Cédric Arvieux, PH

Role: PRINCIPAL_INVESTIGATOR

Rennes 35

Serge Herson, PH

Role: PRINCIPAL_INVESTIGATOR

Pitié Salpétrière Paris

Jean François Bergmann, PH

Role: PRINCIPAL_INVESTIGATOR

Lariboisière Paris

André Cabié, PH

Role: PRINCIPAL_INVESTIGATOR

Fort de France 97( Martinique)

Locations

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BESSON

Paris, , France

Site Status

Countries

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France

References

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Lievin R, Maillard A, Hendel-Chavez H, Krzysiek R, Lancar R, Algarte-Genin M, Costagliola D, Assoumou L, Taoufik Y, Besson C. Immune reconstitution and evolution of B-cell-stimulating cytokines after R-CHOP therapy for HIV-associated DLBCL. Blood Adv. 2024 Dec 10;8(23):6017-6027. doi: 10.1182/bloodadvances.2024014116.

Reference Type DERIVED
PMID: 39348664 (View on PubMed)

Other Identifiers

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2007-AO0258-45

Identifier Type: -

Identifier Source: org_study_id