Chronic Hepatitis C
Conditions
Keywords
B-Cell Non Hodgkin Lymphomas, Hepatitis C
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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.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.
Interventions
None listed
Sponsors
ANRS, Emerging Infectious Diseases
Study design
Observational model
CASE_ONLY
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| haematological response | Month 60 | to evaluate the correlation between hematological and virological response |
Countries
France
Outcome results
None listed