Molecular Analysis of Oncogenes in Tumor Samples From Adult Patients With Intrahepatic Cholangiocarcinoma or Mixed Hepatocellular-Cholangiocarcinoma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 主要终点
- Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
研究概览
简要总结
The primary objective of this study is to estimate the frequency of FGFR2 fusions in archived intrahepatic cholangiocarcinoma (iCCA) or mixed hepatocellular-cholangiocarcinoma (HCC-CCA) tumor samples
详细描述
This is a non-interventional, observational study of archived human tissue samples; no surgical procedures will be required and no treatment will be provided as part of this study. Approximately 150 archived tissue samples obtained from patients with iCCA or mixed HCC-CCA will be analyzed for somatic alteration status and will include cholangiocarcinoma-specific FGFR2 fusion isoforms.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
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
- •If required by law or local regulations (i.e., the sample is from an identifiable subject), signed written informed consent should be granted prior to use of the sample in the study
- •≥ 18 years of age
- •Histologically or cytologically confirmed iCCA or mixed HCC-CCA, who are/were eligible for systemic therapy (samples collected prior to initiation of the systemic therapy may be submitted for testing)
- •Have one or more formalin fixed and paraffin embedded blocks available. If blocks are not evaluable, 7-10 unstained, non-baked slides with 5-micron thick sections with at least 20% tumor tissue should be available. (Potential participants who are scheduled to undergo surgical treatment may agree to provide surplus of tissues not required for diagnosis and have to provide informed consent prior to the surgery.)
排除标准
- •Not applicable: Patients must meet all of the inclusion criteria.
结局指标
主要结局
Estimate the frequency of FGFR2 fusions in archived iCCA or mixed HCC-CCA tumor tissue samples
时间窗: Archived tumor samples will be collected through study completion, up to 18 months
Archived tumor samples will be collected and analyzed using a Next Generation Sequencing panel.
次要结局
- Formulate genetic screening recommendations for newly diagnosed patients with iCCA or mixed HCC-CCA(Archived tumor samples will be collected through study completion, up to 18 months)
- Determine the frequency of potential actionable mutations or genetic alterations in iCCA or mixed HCC-CCA(Archived tumor samples will be collected through study completion, up to 18 months)