Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)

NCT ID: NCT01545544

Last Updated: 2014-02-07

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

UNKNOWN

Total Enrollment

138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2014-11-30

Brief Summary

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An prospective / retrospective multicenter observational study whose objectives are to understand the interactions between hepatitis c virus and Non Hodgkin lymphomas. The characteristics , evolution and treatment of diseases will be observed from the study.

Detailed Description

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Main objectives are:

* Description of the clinical and histological characteristics, treatment and evolution of these NHL.
* Study their physiopathology by immunological, virologic and molecular studies.

The study included prospective or retrospective patients with B- Cell Non-Hodgkin lymphomas (NHL) associated with chronic hepatitis C. The patients are diagnosed or in remission of lymphoma, in relapse or failure of treatments.

The enrolment period is 6 years and the total study lasts 8 years.

* "Prospective patients" are followed every 6 months during one year, and all the years during 2 or 5 years.
* "Retropective patients" are followed all the years during 2 or 5 years. At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.

The enrollment is estimated at 140 patients.

Conditions

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Chronic Hepatitis C

Study Design

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Observational Model Type

CASE_ONLY

Eligibility Criteria

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Inclusion Criteria

* Patients with evolving NHL whatever its histological type
* At diagnosis or relapse or failure previous treatments stopped over 3 months
* Patients with HCV infection with positive quantitative viral load
* 18 years or more of age
* Life expectancy greater than 6 months
* Signed and informed consent
* Benefit from social security

Exclusion Criteria

* Active uncontrolled infection (out hepatitis C)
* HIV (Human immunodeficiency virus) infection
* Severe psychiatric history
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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ANRS, Emerging Infectious Diseases

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Olivier HERMINE, PU-PH

Role: PRINCIPAL_INVESTIGATOR

Hôpital Necker (Paris 15è), Service d'hématologie

Fabrice CARRAT, PU-PH

Role: STUDY_CHAIR

Unité INSERM 707

Locations

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Hôpital Necker

Paris, , France

Site Status

Countries

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France

References

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Michot JM, Canioni D, Driss H, Alric L, Cacoub P, Suarez F, Sibon D, Thieblemont C, Dupuis J, Terrier B, Feray C, Tilly H, Pol S, Leblond V, Settegrana C, Rabiega P, Barthe Y, Hendel-Chavez H, Nguyen-Khac F, Merle-Beral H, Berger F, Molina T, Charlotte F, Carrat F, Davi F, Hermine O, Besson C; ANRS HC-13 Lympho-C Study Group. Antiviral therapy is associated with a better survival in patients with hepatitis C virus and B-cell non-Hodgkin lymphomas, ANRS HC-13 lympho-C study. Am J Hematol. 2015 Mar;90(3):197-203. doi: 10.1002/ajh.23889. Epub 2014 Nov 24.

Reference Type DERIVED
PMID: 25417909 (View on PubMed)

Related Links

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http://anrs.fr

Related Info

Other Identifiers

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ANRS HC13 Lympho C

Identifier Type: -

Identifier Source: org_study_id

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