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
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

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