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NCT04459468 Clinical Trial

Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

Hepatocellular Carcinoma Clinical Trial

Official title:
Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for Hepatocellular Carcinoma (HCC)

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04459468
Other study ID # STU-2019-1758
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 4, 2022
Est. completion date December 2025

Study information
Verified date December 2023
Source University of Texas Southwestern Medical Center
Contact Claire Starcke, BS
Phone 214-648-8152
Email Charlton.Starcke@UTSouthwestern.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study will enroll patients with hepatocellular carcinoma being planned for TACE or other standard of care treatment and obtain blood samples pre and post TACE for biomarker identification using bead based X-aptamer library. No intervention is planned.

Description:

This is a prospective, non-blinded, multi-arm study. Patients at 18 - 70 years old with liver cancer will be enrolled. The approach is to identify novel proteomic biomarkers for HCC patients treated with Lipiodol TACE using beads-based X-aptamer library, then validate and create a biomarker panel that can be used to predict the outcome of HCC post-Lipiodol TACE treatment. Lipiodol TACE will be done as standard of care and the only thing done as research will be blood draws pre and post-TACE.

Recruitment information / eligibility
Status Recruiting
Enrollment 60
Est. completion date December 2025
Est. primary completion date December 2024
Accepts healthy volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. Ability to understand and the willingness to sign a written informed consent. 2. Male or female aged 18-70years. 3. Diagnosed with primary or metastatic liver cancer. 4. Scheduled to undergo Lipoidal TACE, denovo ablation, or Yttrium-90 (Y90) radioembolization as part of standard of care. Exclusion Criteria: Subjects who have received chemotherapy, radiation or surgery for HCC.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Lipiodol
Lipiodol TACE procedure

Locations
Country Name City State
United States UT Southwestern Medical Center Dallas Texas

Sponsors (1)
Lead Sponsor Collaborator
University of Texas Southwestern Medical Center

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP. 2 years
Secondary Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients. X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE . 2 years
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