Extracellular RNA Markers of Liver Disease and Cancer

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Extracellular RNA Markers of Liver Disease and Cancer

Conditions
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Hepatocellular Carcinoma, Biliary Tract Cancer, Cirrhosis, Liver Diseases

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hepatocellular Carcinoma<br>Blood samples will be collected at entry into the study and at varying intervals over a two to three year period. | Other: Blood samples<br>* Blood samples collected at varying intervals over a two to three year period.<br>|
| Biliary Tract Cancer<br>Blood samples will be collected at entry into the system and at varying intervals over a two to three year period. | Other: Blood samples<br>* Blood samples collected at varying intervals over a two to three year period.<br>|
| Cirrhosis<br>Blood samples will be collected during regular intervals over a three year period. | Other: Blood samples<br>* Blood samples collected at varying intervals over a two to three year period.<br>|
| Chronic Liver Disease without Cirrhosis<br>A single blood sample will be collected at entry into the study | Other: Blood samples<br>* Blood samples collected at varying intervals over a two to three year period.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of liver cancer based on tumor markers and imaging studies. | 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 case-control 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 alphafetoprotein. | Five years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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liver cancer, cholangiocarcinoma (CCA), cirrhosis, hepatitis, bile duct cancer, hepatocellular carcinoma (HCC), hepatobiliary carcinoma, hepatoma, liver mass