Molecular Epidemiology of Biliary Tree Cancers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,500
- 试验地点
- 1
- 主要终点
- Significant factors that may contribute to the etiology of biliary tree cancer
研究概览
简要总结
This study is to learn if certain risk factors (environmental, viral, behavioral, medical, and dietary), tumor markers, and genetic changes can predict the development and outcome of biliary tree cancers. Establishing biomarkers models from patients may help doctors to further understand how biliary tree cancer is affected by different treatments, and why some people's cancer responds differently than others.
详细描述
PRIMARY OBJECTIVES:
I. To identify significant factors that may contribute to the etiology of biliary tree cancer.
II. To identify novel genetic loci that predispose to gallbladder cancers (GBC) and cholangiocarcinoma (CGC) diagnosis.
EXPLORATORY AND CORRELATIVE OBJECTIVES:
I. To use the collected blood and tissue materials for exploratory analysis to identify markers that predict prognosis of biliary tree cancers.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pathologically or radiologically confirmed diagnosis of CGC or GBC
- •With or without prior radiation or chemotherapy
- •All United States of America (USA) and non USA residents
- •No age, gender, or racial restriction
- •Healthy control with no current or history of cancer
- •Healthy controls are USA and non USA residents
- •Healthy controls are matched to the cases in age (5 years), gender, and race
- •Healthy controls are friends and spouses of patients with other than gastro-intestinal (GI) cancers
- •Chronic Liver Disease (CLD) controls with no current or history of cancer
- •CLD controls are USA and non USA residents
- •CLD controls are frequency matched to CGC cases by age (5 years), gender, and race
- •CLD controls are patients are diagnosed with or without liver biopsy (core or fine needle aspiration)
- •CLD controls must not have evidence liver cancer diagnosis by computed tomography (CT) or magnetic resonance imaging (MRI)
排除标准
- 未提供
研究组 & 干预措施
Observational (biospecimen collection, questionnaire)
Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.
干预措施: Biospecimen Collection (Procedure)
Observational (biospecimen collection, questionnaire)
Participants complete a questionnaire over 20 minutes. Participants also undergo collection of blood and leftover tissue samples.
干预措施: Questionnaire Administration (Other)
结局指标
主要结局
Significant factors that may contribute to the etiology of biliary tree cancer
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点