Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) Associated With Hepatitis C Virus (HCV) (Lympho C)
|ClinicalTrials.gov Identifier: NCT01545544|
Recruitment Status : Unknown
Verified June 2013 by French National Institute for Health and Medical Research-French National Agency for Research on AIDS and Viral Hepatitis (Inserm-ANRS).
Recruitment status was: Active, not recruiting
First Posted : March 6, 2012
Last Update Posted : February 7, 2014
|Condition or disease|
|Chronic Hepatitis C|
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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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|
|Actual Enrollment :||138 participants|
|Official Title:||Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus|
|Study Start Date :||November 2006|
|Estimated Primary Completion Date :||November 2014|
|Estimated Study Completion Date :||November 2014|
- 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
- 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 ]HCV quantitative viral load
- haematological response [ Time Frame: Month 60 ]to evaluate the correlation between hematological and virological response
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01545544
|Principal Investigator:||Olivier HERMINE, PU-PH||Hôpital Necker (Paris 15è), Service d'hématologie|
|Study Chair:||Fabrice CARRAT, PU-PH||Unité INSERM 707|