Genetic Profiling of Liver Cancer in Patients Undergoing Liver Transplantation

Completed

• Conditions: Hepatocellular Carcinoma
• Interventions: Other: None - Standard of Care

• Registration Number: NCT02412579
• Lead Sponsor: Baylor Research Institute

Brief 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.

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 Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-04-06
• Study First Submitted QC: 2015-04-06
• Study First Posted: 2015-04-09
• Primary Completion: 2022-03-17
• Study Completion: 2022-03-17
• Status Verified: 2022-07
• Last Update Submitted: 2022-07-19
• Last Update Posted: 2022-07-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Hepatocellular Carcinoma with Cirrhosis	None - Standard of Care	Subjects with hepatocellular carcinoma and cirrhosis.
Cirrhosis without Hepatocellular Carcinoma	None - Standard of Care	Subjects with only cirrhosis.

Primary Outcome Measures

Name	Time	Method
Using next-generation sequencing methods to detect isomiRs across different HCC cohorts at all stages undergoing liver transplantation.	One year

Trial Locations

Locations (1)

Baylor University Medical Center; 🇺🇸 Dallas, Texas, United States