Extracellular RNA Markers of Liver Disease and Cancer

N/AActive Not RecruitingNCT02908048

Mayo Clinic1,810 enrolled

Overview

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

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.

Study Type

OBSERVATIONAL

Enrollment

1,810

Conditions

Hepatocellular Carcinoma Biliary Tract Cancer Cirrhosis Liver Diseases

Interventions

Blood samplesOTHER

Blood samples collected at varying intervals over a two to three year period.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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).

Locations (4)

Mayo Clinic Florida

Jacksonville, Florida, United States

The University of Chicago Medical Center

Chicago, Illinois, United States

Mayo Clinic

Rochester, Minnesota, United States

McGuire VA Medical Center

Richmond, Virginia, United States

Outcomes

Primary Outcomes

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.

Time frame: Five years

Data from ClinicalTrials.gov

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