A Clinical Study to Characterize Baseline Biomarker Variability in Participants With Hepatocellular Carcinoma for Utilization of Target Engagement and Pharmacodynamic Biomarkers in Future Phase I Trials
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 入组人数
- 12
- 主要终点
- Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
研究概览
简要总结
The purpose of this study is to characterize the baseline variability of a panel of tissue (tumor and adjacent) and blood-based biomarkers obtained from participants with hepatocellular carcinoma (HCC). The primary hypothesis is that the upper bound of the 80% Confidence Interval of log beta-catenin protein or messenger RNA (mRNA) expression from one core needle biopsy (CNB) equivalent is =< 0.65.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •Diagnosed with HCC.
- •Candidate for surgical resection or has no contraindications to MRI procedures.
排除标准
- •Prior loco-regional treatment of tumor, unless there is untreated tumor present representing a distinct untreated nodule.
- •Confirmed or suspected diagnosis of fibrolamellar HCC, mixed HCC/cholangiocarcinoma or metastatic tumor.
- •Had a liver transplant.
结局指标
主要结局
Expression Levels of Beta-catenin mRNA From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
时间窗: Visit 3, approximately 7 days after screening Visit 1.
Resected tumors were fixed with formalin in paraffin embedded (FFPE) blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin messenger RNA (mRNA) by quantitative reverse transcription polymerase chain reaction (qRT-PCR).
Expression Levels of Beta-catenin Protein From Core Needle Biopsy (CNB) Equivalents of Resected HCC.
时间窗: Visit 3, approximately 7 days after screening Visit 1.
Resected tumors were fixed in FFPE blocks, which were used to prepare multiple serial slide sections. The sections were to be analyzed for beta-catenin protein by automated image analysis.
次要结局
- Expression Levels of Beta-catenin mRNA From CNB Equivalents of Liver Adjacent to HCC.(Visit 3, approximately 7 days after screening Visit 1.)
- Expression Levels of Beta-catenin Protein From CNB Equivalents of Liver Adjacent to HCC.(Visit 3, approximately 7 days after screening Visit 1.)
- Tumor Volumes From Repeated MRI Measurements of HCC.(Visit 2, approximately 7 days after screening Visit 1.)
- Median Apparent Diffusion Coefficient (Median ADC) of Tumors From Repeated MRI Measurements of HCC.(Visit 2, approximately 7 days after screening Visit 1.)
- Expression Levels of Low Density Lipoprotein Receptor (LDL-R) in Resected HCC and Adjacent Liver From Whole Tissue Sections.(Visit 3, approximately 7 days after screening Visit 1.)