Novel HBV Biomarkers to Assess the Risk of Reactivation of Occult Hepatitis B in Cancer Patients During Immunotherapy: an Observational Prospective Multicenter Study.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV
研究概览
简要总结
The goal of this observational study is to evalue the cumulative proportion of patients with OBI who do not develop HBsAg seroreversion and/or an increase of serum HBV DNA by at least 1 log above the lower limit of detection of the assay in a patient who had previously undetectable HBsAg and HBV DNA in serum during the study.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Life-expectancy (as estimated by treating physician) ≥ 6 months;
- •Patients HBsAg negative
- •Patients HBcAb positive with or without HBV-DNA detectable
- •Patients with cancer undergoing immunotherapy with or without chemotherapy
排除标准
- •Patients who did not give informed consent
- •Patients under prophylaxis for HBV
- •Patients vaccinated for hepatitis B
- •Patients with HBsAg positivity
- •Patients with HIV positivity
- •Patients with current history of alcohol (more than 5 alcohol unit daily) and drug use
- •Patients with other cause of liver disease with known etiology (autoimmune liver disorder and storage liver disease)
- •Patients with current active Hepatitis C virus (HCV-positive)
- •Patients with hepatocellular carcinoma (HCC)
结局指标
主要结局
To evaluate the cumulative proportion of patients with OBI who do not develop one seroreversion of HBsAg and/or an increase in serum HBV DNA of at least 1 log above the lower limit of detection of the test in a patient who had previously HBsAg and HBV
时间窗: 3 weeks after first cycle of therapy and every 3 months until the end of the study
Occult hepatitis B (OBI) detectable in serum HBV DNA, negative antigen test surface hepatitis B (HBsAg) and with positivity to anti-HBc (OBI seropositive). pOBI: Based on the intermittent detection of HBV DNA, we define pOBI (OBI potential) patients with negative HBV-DNA and positivity to anti-HBc.
次要结局
- Analysis of the incidence of reactivation of HBV in patients with p-OBI according to tumor characteristics (histology and stage) and type and line of treatment (immunotherapy, combined treatment with chemotherapy + immunotherapy).(3 weeks after first cycle of therapy and every 3 months until the end of the study)
- Evaluation of the incidence of reactivation in patients during immunotherapy(3 weeks after first cycle of therapy and every 3 months until the end of the study)
- Evaluation of the association between HBV-specific T-cell response and HBV reactivation(3 weeks after first cycle of therapy and every 3 months until the end of the study)
研究者
Angioletta Lasagna
Principal Investigator
Fondazione IRCCS Policlinico San Matteo di Pavia