Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

University of Texas Southwestern Medical Center17 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hepatocellular Carcinoma

Interventions

LipiodolDRUG

Lipiodol TACE procedure

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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.

Locations (1)

UT Southwestern Medical Center

Dallas, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 2 years

Secondary Outcomes

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 .

Time frame: 2 years

Data from ClinicalTrials.gov

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