Extracellular RNA Markers of Liver Disease and Cancer

March 12, 2024 updated by: Tushar Patel, Mayo Clinic
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

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1810

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic Florida
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago Medical Center
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic
    • Virginia
      • Richmond, Virginia, United States, 23249
        • McGuire VA Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

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.

Description

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).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
Blood samples collected at varying intervals over a two to three year period.
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
Blood samples collected at varying intervals over a two to three year period.
Cirrhosis
Blood samples will be collected during regular intervals over a three year period.
Other: Blood samples
Blood samples collected at varying intervals over a two to three year period.
Chronic Liver Disease without Cirrhosis
A single blood sample will be collected at entry into the study
Other: Blood samples
Blood samples collected at varying intervals over a two to three year period.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of liver cancer based on tumor markers and imaging studies.
Time Frame: 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.
Five years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Tushar Patel, MBChB, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Estimated)

July 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

September 14, 2016

First Submitted That Met QC Criteria

September 16, 2016

First Posted (Estimated)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 13, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-004560

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Liver Diseases

Clinical Trials on Blood samples

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Slovenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe