Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

July 19, 2022 updated by: Baylor Research Institute

Circulating MicroRNA Isoforms as Biomarkers in Hepatocellular Carcinoma and Associated Liver Transplantation

The purpose of this study is to determine whether genetic markers unique to liver cancer are present and to assess usefulness as a diagnostic tool.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is the most common form of liver cancer and a growing trend worldwide. Decision-making regarding treatment for patients is limited by the lack of clinically actionable biomarkers. This is pronounced in the case for determining and monitoring liver transplant recipients. In an effort to improve diagnosis, the use of circulating serum-based microRNA isoforms (isomiRs) can serve as non-invasive, screening biomarkers in HCC patients pre- and post-transplantation of the liver.

Study Type

Observational

Enrollment (Actual)

40

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
    • Texas
      • Dallas, Texas, United States, 75246
        • Baylor University 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 to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Hepatocellular Carcinoma Clinic Pre-Liver Transplant Clinic

Description

Inclusion Criteria:

  • Patients with the diagnosis of HCC who are on the wait list for liver transplantation
  • Patients with the diagnosis of HCC who have been admitted to hospital, scheduled to undergo liver transplantation within the following 24 hours.
  • Age Range: 18 to 75 years old

Exclusion Criteria:

  • Patients with metastatic HCC and patients with the diagnosis of HCC who are not on the wait list for liver transplantation.
  • Patients older than 75 years old and younger than 18 years old.
  • Patients who are unable to consent.
  • Pregnant patients.

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: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Hepatocellular Carcinoma with Cirrhosis
Subjects with hepatocellular carcinoma and cirrhosis.
Other: None - Standard of Care
Cirrhosis without Hepatocellular Carcinoma
Subjects with only cirrhosis.
Other: None - Standard of Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.
Time Frame: One year
One year

Collaborators and Investigators

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

Sponsor

Baylor Research Institute

Investigators

  • Principal Investigator: Peter Kim, M.D., Annette C. & Harold C. Simmons Transplant Institute

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 (Actual)

March 1, 2015

Primary Completion (Actual)

March 17, 2022

Study Completion (Actual)

March 17, 2022

Study Registration Dates

First Submitted

April 6, 2015

First Submitted That Met QC Criteria

April 6, 2015

First Posted (Estimate)

April 9, 2015

Study Record Updates

Last Update Posted (Actual)

July 20, 2022

Last Update Submitted That Met QC Criteria

July 19, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 014-121

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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.

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