Extracellular RNA Markers of Liver Disease and Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

Extracellular RNA Markers of Liver Disease and Cancer

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02908048
• Other study ID #: 14-004560
• Status: Active, not recruiting
• Start date: July 2014
• Est. completion date: July 2026

Study information

• Verified date: March 2024
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1810
• Est. completion date: July 2026
• Est. primary completion date: July 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Biliary Tract Cancer
• Biliary Tract Neoplasms
• Carcinoma
• Carcinoma, Hepatocellular
• Cirrhosis
• Fibrosis
• Hepatocellular Carcinoma
• Liver Diseases

Intervention

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

Locations

Country	Name	City	State
United States	The University of Chicago Medical Center	Chicago	Illinois
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	McGuire VA Medical Center	Richmond	Virginia
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Mayo Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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