2017-01: Blood Sample Collection to Evaluate Biomarkers for Hepatocellular Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,150
- 试验地点
- 73
- 主要终点
- Biomarker Identification
研究概览
简要总结
The primary objective of this study is to obtain de-identified, clinically-characterized whole blood specimens for use in developing and evaluating the performance of new biomarker assays for detection of hepatocellular carcinoma (HCC).
详细描述
Subjects with untreated Hepatocellular Carcinoma (HCC) and subjects undergoing HCC surveillance will be enrolled and have blood samples collected. Subjects undergoing HCC surveillance will be followed for up to 6 months. Another blood sample will be collected at the 6 month visit which will be scheduled no longer than 6 months from enrollment.
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
- •All Subjects:
- •Subject is 18 years of age or older
- •Subject understands the study procedures and is able to provide informed consent to participate in the study and authorization for release of data, including personal health data, to the study investigator and sponsor
- •HCC Subjects:
- •Subject has a recent (within 6 months of enrollment) untreated clinically diagnosed hepatocellular carcinoma as defined by ≥1 cm lesion exhibiting arterial phase hyperenhancement in combination with washout appearance and/or capsule by 4 phase CT scan or multiphase contrast enhanced MRI or biopsy is positive for HCC.
- •Control Subjects:
- •Non-cancer subject undergoing routine imaging surveillance for HCC
- •Definitive lack of HCC within 3 months prior to enrollment as defined by negative imaging, for HCC.
- •Control Group 1 - negative by ultrasound
- •Control Group 2 - negative by CT or MRI
排除标准
- •Known cancer diagnosis within the past 5 years (with the exceptions of basal cell or squamous cell skin cancers).
- •Chemotherapy and/or radiation therapy within 5 years prior to enrollment/sample collection.
- •Prior or current treatment with sorafenib, regorafenib, or other treatment indicated for HCC.
- •Any HCC treatment prior to enrollment/blood sample collection (e.g., surgery, ablation, embolization, pharmacotherapy, radiotherapy, liver transplant or other treatment indicated for HCC).
- •IV contrast (e.g. CT and MRI) within 1 day [or 24 hours] of blood collection.
- •Less than 3 days between fine needle aspiration (FNA) of target pathology and blood collection.
- •Less than 7 days between biopsy (other than FNA) of target pathology and blood collection.
- •Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk.
结局指标
主要结局
Biomarker Identification
时间窗: 1 year
Biomarkers under evaluation include differential methylation of nucleic acids and altered expression of proteins in blood from subjects with HCC compared to those without (but are at risk of developing the disease so are under surveillance)
次要结局
未报告次要终点