Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV)
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|
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.
presentation of NHL and HCV infection, and treatments of NHL and HCV infection
time frame: at the first visit (Day 0)
Summary of intercurrents biological and clinical events
time frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60
time frame: Month 60
time frame: Month 60
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
|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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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.|
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