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

February 6, 2014 updated by: ANRS, Emerging Infectious Diseases

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

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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.

Study Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Paris, France
        • Hopital Necker

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Adult patients with HCV infection with positive viral load and a B-cell NHL.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presentation of NHL and HCV infection, and treatments of NHL and HCV infection
Time Frame: at the first visit (Day 0)
the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics
at the first visit (Day 0)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Summary of intercurrents biological and clinical events
Time Frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
virological response
Time Frame: Month 60
HCV quantitative viral load
Month 60
haematological response
Time Frame: Month 60
to evaluate the correlation between hematological and virological response
Month 60

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

ANRS, Emerging Infectious Diseases

Investigators

  • Principal Investigator: Olivier HERMINE, PU-PH, Hôpital Necker (Paris 15è), Service d'hématologie
  • Study Chair: Fabrice CARRAT, PU-PH, Unité INSERM 707

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2006

Primary Completion (Anticipated)

November 1, 2014

Study Completion (Anticipated)

November 1, 2014

Study Registration Dates

First Submitted

February 21, 2012

First Submitted That Met QC Criteria

March 1, 2012

First Posted (Estimate)

March 6, 2012

Study Record Updates

Last Update Posted (Estimate)

February 7, 2014

Last Update Submitted That Met QC Criteria

February 6, 2014

Last Verified

June 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ANRS HC13 Lympho C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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