Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

Circulating MicroRNA Levels as a Predictor of Successful Bridging or Down-Staging Loco-Regional Therapy (LRT) to Liver Transplantation for Patients With Hepatocellular Carcinoma (HCC)

This study investigates if an experimental blood test can help predict how well cancer will remain under control with treatment. Ther experimental blood test involves measuring mircoRNAs. MicroRNAs are small molecules which help regulate how genes are expressed. This information may help researchers guide treatment for other patients in the future.

Study Overview

• Status: Completed
• Conditions: Hepatocellular Carcinoma

• Study Type: Observational
• Enrollment (Actual): 7

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Thomas Jefferson University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Patientss with hepatocellular carcinoma felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy

Description

Inclusion Criteria:

• Provide signed and dated informed consent form
• Willing to comply with all study procedures and be available for the duration of the study
• Definite diagnosis of hepatocellular carcinoma established (by standard radiographic or histologic criteria)
• Felt to be reasonable candidate for liver transplantation, potentially contingent on success of down-staging therapy

Exclusion Criteria:

• Either active or recent solid organ cancer other than hepatocellur carcinoma (HCC) within the last 5 years, unless determined by transplant hepatology team not to represent contra-indication to liver transplantation
• Contra-indication to LRT (as assessed by interventional radiologist, for example severe thrombocytopenia, severe vascular disease precluding access, etc)
• History of prior liver transplantation
• Active or prior systemic therapy for HCC

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Patient Clinical Status - Liver Transplant	Undergoing liver transplant	At study completion, up to 12 months
Patient Clinical Status - Death	Will assess the following: death	At study completion, up to 12 months
Patient Clinical Status - Candidacy	No longer candidate for transplantation for reasons other than tumor progression	At study completion, up to 12 months
Patient Clinical Status	No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts	At study completion, up to 12 months
Incidence of "Wait List Drop Off"	Will be estimated and presented with a Clopper-Pearson exact binomial confidence interval	At study completion, up to 12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to "Wait List Drop Off"	Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to "wait list drop off"	Up to 12 months
Clinical Status of the subset of patients successfully reaching liver transplant	Logistic regression modeling will be used to investigate the correlation of each miRNA with clincial status (alive without recurrence vs. recurrence or death) within one year of transplant will be cinducted in the subset of those undergoing transplant. The p-values will be adjusted for false discovery rate inflation by the methods of Benjamni & Hochberg (1995) for both secondary analyses, respectively	At 1 year after transplantation

Collaborators and Investigators

• Sponsor: Thomas Jefferson University

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2019
• Primary Completion (Actual): February 15, 2023
• Study Completion (Actual): November 9, 2023

Study Registration Dates

• First Submitted: December 7, 2020
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 22, 2021

Study Record Updates

• Last Update Posted (Actual): April 29, 2025
• Last Update Submitted That Met QC Criteria: April 28, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Neoplasms by Histologic Type; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular
• Other Study ID Numbers: 19D.737; JT 13572 (Other Identifier: JeffTrial Number)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No