Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC (Lipiodol TACE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Hepatocellular Carcinoma
• Intervention / Treatment: Drug: Lipiodol

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 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.

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Claire Starcke, BS; Phone Number: 214-648-8152; Email: Charlton.Starcke@UTSouthwestern.edu

Study Locations

• United States
  • Texas
    • Dallas, Texas, United States, 75390
      • Recruiting
      • UT Southwestern Medical Center
      • Contact: Claire Starcke, BS; Phone Number: 214-648-8152; Email: Charlton.Starcke@UTSouthwestern.edu
      • Principal Investigator: Anil Pillai, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Probability Sample

Study Population

Patients with HCC

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy controls; Healthy controls from public database
HCC patients; HCC patients will be used for biomarker validation.
HCC for Lipiodol TACE, denovo ablation, or Y90 radioembolization; These patients will receive standard of care Lipiodol TACE, denovo ablation, or Y90 radioembolization treatment. No research intervention is planned.	Drug: Lipiodol; Lipiodol TACE procedure

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Texas Southwestern Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2025

Study Registration Dates

• First Submitted: July 1, 2020
• First Submitted That Met QC Criteria: July 1, 2020
• First Posted (Actual): July 7, 2020

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 6, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Neoplasms by Histologic Type; Neoplasms; Neoplasms by Site; Adenocarcinoma; Neoplasms, Glandular and Epithelial; Digestive System Neoplasms; Liver Diseases; Liver Neoplasms; Carcinoma; Carcinoma, Hepatocellular; Antineoplastic Agents; Ethiodized Oil
• Other Study ID Numbers: STU-2019-1758

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No