Observational Study of B-Cell Non Hodgkin Lymphomas (NHL) in Patients With Hepatitis C Virus
试验速览
- 阶段
- 不适用
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- presentation of NHL and HCV infection, and treatments of NHL and HCV infection
研究概览
简要总结
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.
详细描述
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 At each follow-up, a blood sample of 50ml is withdrawn allowing ancillary studies.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Active uncontrolled infection (out hepatitis C)
- •HIV (Human immunodeficiency virus) infection
- •Severe psychiatric history
结局指标
主要结局
presentation of NHL and HCV infection, and treatments of NHL and HCV infection
时间窗: at the first visit (Day 0)
the presentation of NHL and HCV infection is done by clinical,histological and biological characteristics
次要结局
- haematological response(Month 60)
- Summary of intercurrents biological and clinical events(Month 6, Month 12, Month 24, Month 36, Month 48 and Month 60)
- virological response(Month 60)