A Prospective Observational Study to Assess Monoclonal B-Cell Lymphocytosis in Individuals With Chronic Hepatitis C
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 29
- 试验地点
- 1
- 主要终点
- Prevalence of monoclonal B-cell lymphocytosis (MBL)
研究概览
简要总结
This study evaluates the incidence of monoclonal B-cell lymphocytosis MBL) in patients with chronic hepatitis C and to determine if monoclonal b-cell lymphocytosis is affected by treatment for hepatitis C.
详细描述
PRIMARY OBJECTIVES:
I. To determine the prevalence of MBL in patients with chronic hepatitis C who are to begin therapy with directly acting antiviral (DAA), and compare with clinic controls who are seen in the general medicine clinic at Mayo Clinic.
II. To determine the correlation between the specific subtype of MBL (CD5- MBL, atypical CLL-phenotype MBL and CLL-phenotype MBL) relative to the hepatitis C virus (HCV) genotype.
III. To assess the proportion of individuals with MBL who have an improvement in the circulating monoclonal B-cell population following therapy with DAA.
OUTLINE: This is an observational study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Individuals with chronic hepatitis C who are to begin therapy with DAA
- •Willing to submit a peripheral blood sample at baseline, end of therapy, 12 weeks after the end of therapy, and 52 weeks from baseline
排除标准
- •Individuals with chronic hepatitis C who have cirrhosis
- •Individuals with chronic hepatitis C who have a past history of a lymphoproliferative disorder AND for which they received chemotherapy
结局指标
主要结局
Prevalence of monoclonal B-cell lymphocytosis (MBL)
时间窗: Baseline; up to one year
Blood samples collected in conjunction with routine clinical blood draws will be tested for MBL and compared with post-therapy samples and with control patients (without hepatitis C).
次要结局
未报告次要终点