Blood Sample Collection for Experimental Blood Test to Track Liver Cancer

Hepatocellular Carcinoma Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04720430
• Other study ID #: 19D.737
• Status: Completed
• Start date: December 3, 2019
• Est. completion date: November 9, 2023

Study information

• Verified date: November 2023
• Source: Thomas Jefferson University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: November 9, 2023
• Est. primary completion date: February 15, 2023
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Locations

Country	Name	City	State
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Jefferson University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Clinical Status - Liver Transplant	Undergoing liver transplant	At study completion, up to 12 months
Primary	Patient Clinical Status - Death	Will assess the following: death	At study completion, up to 12 months
Primary	Patient Clinical Status - Candidacy	No longer candidate for transplantation for reasons other than tumor progression	At study completion, up to 12 months
Primary	Patient Clinical Status	No longer candidate for transplantation due to tumor progression despite loco-regional therapy efforts	At study completion, up to 12 months
Primary	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	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
Secondary	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