NCT02908048

Extracellular RNA Markers of Liver Disease and Cancer

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,810 (actual)
• Sponsor: Mayo Clinic · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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

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.

Conditions

• Hepatocellular Carcinoma
• Biliary Tract Cancer
• Cirrhosis
• Liver Diseases

Interventions

Type	Name	Description
OTHER	Blood samples	Blood samples collected at varying intervals over a two to three year period.

Timeline

• Start date: 2014-07-01
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2016-09-20
• Last updated: 2025-04-06

Locations

4 sites across 1 country: United States