Extracellular RNA Markers of Liver Disease and Cancer
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Mayo Clinic
- 入组人数
- 1,810
- 试验地点
- 8
- 主要终点
- Diagnosis of liver cancer based on tumor markers and imaging studies.
研究概览
简要总结
The study will examine and evaluate the use of extracellular RNA in blood as markers for the diagnosis of liver disease or cancer, and as markers for prediction of response to treatment or recurrence of cancer after surgery
详细描述
The goal is to identify an extracellular RNA candidate for the detection and diagnosis of liver cancers such as hepatocellular cancer or biliary cancer, and chronic liver diseases. The use of selected exRNA biomarkers for diagnosis of hepatocellular cancer (HCC) or biliary tract cancers in patients with cirrhosis will be evaluated in a prospective case-control study. The study will create a registry of patients who have chronic liver disease, cirrhosis, liver and biliary tract cancers. A risk factor questionnaire will be administered to facilitate identification of risk factors for development of liver cancer. Patient information will be obtained from the medical record, and include demographics, medical history, liver disease, smoking and alcohol history, etiology, family history, and clinical laboratory data.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Lab results from within the previous 90 days.
- •Diagnosis of HCC or biliary tract cancer
- •Diagnosis of cirrhosis based on histology, imaging, or ultrasound.
- •Diagnosis of a chronic liver disease without cirrhosis.
- •Exclusion Criteria for the HCC/biliary tract cancer group:
- •Prior solid organ transplant.
- •Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC
- •Exclusion criteria for the cirrhosis and chronic liver disease groups:
- •Prior solid organ transplant.
- •Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).
排除标准
- 未提供
研究组 & 干预措施
Chronic Liver Disease without Cirrhosis
A single blood sample will be collected at entry into the study
干预措施: Blood samples (Other)
Hepatocellular Carcinoma
Blood samples will be collected at entry into the study and at varying intervals over a two to three year period.
干预措施: Blood samples (Other)
Biliary Tract Cancer
Blood samples will be collected at entry into the system and at varying intervals over a two to three year period.
干预措施: Blood samples (Other)
Cirrhosis
Blood samples will be collected during regular intervals over a three year period.
干预措施: Blood samples (Other)
结局指标
主要结局
Diagnosis of liver cancer based on tumor markers and imaging studies.
时间窗: Five years
The exRNA biomarker levels in the HCC and biliary tract cancer groups will be evaluated and compared to the exRNA biomarker levels present in the other groups, cirrhosis and chronic liver disease. Statistical analysis will be used to evaluate the sensitivity and specificity of these markers for the diagnosis of cancers based on findings of liver mass, imaging characteristics, size, and extent of viable tumor on imaging, or on elevated levels of tumor markers such as alpha-fetoprotein.
次要结局
未报告次要终点