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NCT02412579 Clinical Trial

Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

Hepatocellular Carcinoma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02412579
Other study ID # 014-121
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2015
Est. completion date March 17, 2022

Study information
Verified date July 2022
Source Baylor Research Institute
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date March 17, 2022
Est. primary completion date March 17, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Other:
• None - Standard of Care

Locations
Country Name City State
United States Baylor University Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
Baylor Research Institute

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation. One year
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