Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

Recruiting

• Conditions: Hepatocellular Carcinoma
• Interventions: Drug: Lipiodol

• Registration Number: NCT04459468
• Lead Sponsor: University of Texas Southwestern Medical Center

Brief Summary

This study will enroll patients with hepatocellular carcinoma being planned for TACE or other standard of care treatment (such as denovo ablation or Y90) and obtain blood samples pre and post treatment procedure for biomarker identification using bead based X-aptamer library. No intervention is planned.

Detailed 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, denovo ablation or Y90 using beads-based X-aptamer library, then validate and create a biomarker panel that can be used to predict the outcome of HCC post treatment.

Lipiodol TACE, denovo ablation, or Y90 will be done as standard of care and the only thing done as research will be blood draws pre and post-TACE.

Study Timeline

• Study First Submitted: 2020-07-01
• Study First Submitted QC: 2020-07-01
• Study First Posted: 2020-07-07
• Study Start: 2022-11-04
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-23
• Last Update Posted: 2024-12-27
• Primary Completion: 2025-06
• Study Completion: 2025-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
HCC for Lipiodol TACE, denovo ablation, or Y90 radioembolization	Lipiodol	These patients will receive standard of care Lipiodol TACE, denovo ablation, or Y90 radioembolization treatment. No research intervention is planned.

Primary Outcome Measures

Name	Time	Method
Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients	2 years	X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP.

Secondary Outcome Measures

Name	Time	Method
Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.	2 years	X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE .

Trial Locations

Locations (1)

UT Southwestern Medical Center; 🇺🇸 Dallas, Texas, United States