Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

Completed

• Conditions: Hepatocellular Carcinoma

• Registration Number: NCT04720430
• Lead Sponsor: Thomas Jefferson University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-12-03
• Study First Submitted: 2020-12-07
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-22
• Primary Completion: 2023-02-15
• Study Completion: 2023-11-09
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-28
• Last Update Posted: 2025-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Clinical Status of the subset of patients successfully reaching liver transplant	At 1 year after transplantation	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
Time to "Wait List Drop Off"	Up to 12 months	Cox proportinal hazards modeling will be used to investigate the associations of each micro ribonucleic acid (miRNO) with time to "wait list drop off"

Trial Locations

Locations (1)

Thomas Jefferson University Hospital; 🇺🇸 Philadelphia, Pennsylvania, United States