A Study of Molecular and Genetic Factors for Liver Cancer in the Greater Baltimore Area
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,871
- 试验地点
- 2
- 主要终点
- Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention.
研究概览
简要总结
Background:
- Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary liver cancer, and it has grown more prevalent in the United States.
- More information is needed about the causes and effects of liver cancer, and further research into individuals who are at high risk for developing liver cancer is needed for early diagnosis and prevention.
Objectives:
- To identify genetic factors that may help to explain the aggressiveness of liver cancer.
- To determine if HCC biomarkers exist in blood, urine, and tissue samples.
Eligibility:
- Patients between the ages of 18 and 90 who have been diagnosed with HCC or have a high risk for developing HCC because of fatty liver disease (alcohol-related or non-alcohol-related) or chronic hepatitis B or C.
- Participants will reside in Baltimore City and the surrounding areas.
Design:
- Participants will complete a questionnaire and provide blood and urine samples for testing:
- The questionnaire will include questions about individual and family medical history, tobacco use, and exposure to known factors for liver cancer.
- Blood and urine samples will be collected from all participants after the questionnaire.
- Tumor tissue and healthy tissue will be collected from selected participants if they undergo surgery for their cancer or disease.
- No specific treatment will be offered as part of this protocol, but participants have the option to be treated under different protocols.
详细描述
BACKGROUND:
Liver cancer is the third most deadly and fifth most common cancer worldwide. Hepatocellular carcinoma (HCC) is the most frequent primary cancer of the liver with rising incidence in the United States. HCC patients have a dismal outcome and are an underserved cancer population. We are proposing a liver cancer case-control and case-case study to be conducted in Baltimore, Maryland.
OBJECTIVES:
Our research is aimed to identify genetic and genomic changes that might explain the aggressive nature of liver cancer. We will test the primary hypothesis that HCC biomarkers exist in blood products (or mouth wash), urine and/or tissues that can be used for early diagnosis and prevention. A unique study factor is the use of urine samples for biomarker identification. A secondary goal will be to examine whether certain genetic and genomic factors modify liver cancer susceptibility using candidate and genome wide association study approaches. Although other studies have investigated genetic susceptibility, large scale studies have not been conducted for liver cancer. Our study will also be valuable due to access to frozen tumor specimens from pre-therapy resection, whose collection is required for gene expression analysis. If certain genes are related to HCC risk and progression, this tissue resource will be used to further validate our findings with laboratory investigations. The proposed study is designed to be exploratory and hypothesis generating.
ELIGIBILITY:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Large-scale molecular profiling study to identify HCC biomarkers for early diagnosis and prevention.
时间窗: ongoing
Identification of HCC biomarkers for early diagnosis and prevention.
次要结局
未报告次要终点