Extracellular RNA Markers of Liver Disease and Cancer

NCT02908048 | Terminated

• 1 other identifier: 14-004560
• Study Type: observational
• Target: 1,865
• Locations: 1 country
• Sites: 4

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

Conditions

Hepatocellular Carcinoma; Biliary Tract Cancer; Cirrhosis; Liver Diseases

Keywords

liver cancer; cholangiocarcinoma (CCA); cirrhosis; hepatitis; bile duct cancer; hepatocellular carcinoma (HCC); hepatobiliary carcinoma; hepatoma; liver mass

Outcome Measures

Primary Outcomes (1)

• 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 other 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 alpha-fetoprotein.

  Five years

Study Arms (4)

Hepatocellular Carcinoma

Blood samples will be collected at entry into the study and at varying intervals over a two to three year period.

Other: Blood samples

Biliary Tract Cancer

Blood samples will be collected at entry into the system and at varying intervals over a two to three year period.

Other: Blood samples

Cirrhosis

Blood samples will be collected during regular intervals over a three year period.

Other: Blood samples

Chronic Liver Disease without Cirrhosis

A single blood sample will be collected at entry into the study

Other: Blood samples

Interventions

Blood samples OTHER

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

Biliary Tract Cancer; Chronic Liver Disease without Cirrhosis; Cirrhosis; Hepatocellular Carcinoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing evaluation at Mayo Clinic Florida Liver Transplant, Surgery, Oncology or Radiology clinics who have hepatocellular carcinoma (HCC) or biliary tract cancers, cirrhosis without HCC, or chronic liver disease without cirrhosis.

You may qualify if:

• 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.

You may not qualify if:

• Prior solid organ transplant.
• Previous cancer history with the last 5 years (excluding non-melanoma skin cancer), participation in a treatment trial for HCC
• Prior solid organ transplant.
• Previous or current cancer history within the past 5 years (excluding non-melanoma skin cancer).

Sponsors & Collaborators

• National Center for Advancing Translational Sciences (NCATS): collaborator
• Mayo Clinic: lead

Study Sites (4)

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

The University of Chicago Medical Center

Chicago, Illinois, 60637, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

McGuire VA Medical Center

Richmond, Virginia, 23249, United States

Location

Related Links

• Mayo Clinic Clinical Trials

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Carcinoma, Hepatocellular; Biliary Tract Neoplasms; Fibrosis; Liver Diseases; Liver Neoplasms; Cholangiocarcinoma; Hepatitis; Bile Duct Neoplasms

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Biliary Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Bile Duct Diseases

Intervention Hierarchy (Ancestors)

Specimen Handling; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Punctures; Surgical Procedures, Operative; Investigative Techniques

Study Officials

• Tushar Patel, MBChB

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: September 14, 2016
• First Posted: September 20, 2016
• Study Start: July 1, 2014
• Primary Completion: April 2, 2024
• Study Completion: April 2, 2024
• Last Updated: May 5, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)