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

• Conditions: Chronic Hepatitis C

• Registration Number: NCT01545544
• Lead Sponsor: ANRS, Emerging Infectious Diseases

Brief Summary

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

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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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

• Study Start: 2006-11
• Study First Submitted: 2012-02-21
• Study First Submitted QC: 2012-03-01
• Study First Posted: 2012-03-06
• Status Verified: 2013-06
• Last Update Submitted: 2014-02-06
• Last Update Posted: 2014-02-07
• Primary Completion: 2014-11
• Study Completion: 2014-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 138

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
presentation of NHL and HCV infection, and treatments of NHL and HCV infection	at the first visit (Day 0)	the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hôpital Necker; 🇫🇷 Paris, France