Overview

This trial is active, not recruiting.

Condition chronic hepatitis c
Sponsor French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS)
Start date November 2006
End date November 2014
Trial size 138 participants
Trial identifier NCT01545544, ANRS HC13 Lympho C

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only

Primary Outcomes

Measure
presentation of NHL and HCV infection, and treatments of NHL and HCV infection
time frame: at the first visit (Day 0)

Secondary Outcomes

Measure
Summary of intercurrents biological and clinical events
time frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
virological response
time frame: Month 60
haematological response
time frame: Month 60

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus
Principal investigator Olivier HERMINE, PU-PH
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.
Trial information was received from ClinicalTrials.gov and was last updated in February 2014.
Information provided to ClinicalTrials.gov by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).