Extracellular RNA Markers of Liver Disease and Cancer

Active, not recruiting

• Conditions: Hepatocellular Carcinoma; Liver Diseases; Biliary Tract Cancer; Cirrhosis
• Interventions: Other: Blood samples

• Registration Number: NCT02908048
• Lead Sponsor: Mayo Clinic

Brief 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.

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2016-09-14
• Study First Submitted QC: 2016-09-16
• Study First Posted: 2016-09-20
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-03
• Last Update Posted: 2025-04-06
• Primary Completion: 2026-07
• Study Completion: 2026-07

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 1810

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).

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Biliary Tract Cancer	Blood samples	Blood samples will be collected at entry into the system and at varying intervals over a two to three year period.
Cirrhosis	Blood samples	Blood samples will be collected during regular intervals over a three year period.
Chronic Liver Disease without Cirrhosis	Blood samples	A single blood sample will be collected at entry into the study
Hepatocellular Carcinoma	Blood samples	Blood samples will be collected at entry into the study and at varying intervals over a two to three year period.

Primary Outcome Measures

Name	Time	Method
Diagnosis of liver cancer based on tumor markers and imaging studies.	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 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.

Trial Locations

Locations (4)

The University of Chicago Medical Center; 🇺🇸 Chicago, Illinois, United States

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

Mayo Clinic Florida; 🇺🇸 Jacksonville, Florida, United States

McGuire VA Medical Center; 🇺🇸 Richmond, Virginia, United States