Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV) (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.
Chronic Hepatitis C
|Study Design:||Observational Model: Case-Only|
|Official Title:||Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus|
- presentation of NHL and HCV infection, and treatments of NHL and HCV infection [ Time Frame: at the first visit (Day 0) ] [ Designated as safety issue: No ]the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics
- Summary of intercurrents biological and clinical events [ Time Frame: Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60 ] [ Designated as safety issue: Yes ]
- virological response [ Time Frame: Month 60 ] [ Designated as safety issue: No ]HCV quantitative viral load
- haematological response [ Time Frame: Month 60 ] [ Designated as safety issue: No ]to evaluate the correlation between hematological and virological response
Biospecimen Retention: Samples With DNA
whole blood and bone marrow
|Study Start Date:||November 2006|
|Estimated Study Completion Date:||November 2014|
|Estimated Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01545544
|Principal Investigator:||Olivier HERMINE, PU-PH||Hôpital Necker (Paris 15è), Service d'hématologie|
|Study Chair:||Fabrice CARRAT, PU-PH||Unité INSERM 707|