Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

NCT04459468 | Completed DMC FDA Drug

• 1 other identifier: STU-2019-1758
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.

  2 years

Study Arms (3)

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

Healthy controls

Healthy controls from public database

HCC patients

HCC patients will be used for biomarker validation.

Interventions

Lipiodol DRUG

Lipiodol TACE procedure

HCC for Lipiodol TACE, denovo ablation, or Y90 radioembolization

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with HCC

You may qualify if:

• Ability to understand and the willingness to sign a written informed consent.
• Male or female aged 18-70years.
• Diagnosed with primary or metastatic liver cancer.
• Scheduled to undergo Lipoidal TACE, denovo ablation, or Yttrium-90 (Y90) radioembolization as part of standard of care.

You may not qualify if:

• Subjects who have received chemotherapy, radiation or surgery for HCC.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead

Study Sites (1)

UT Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Pre and Post-treatment procedure blood samples

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

Ethiodized Oil

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Iodized Oil; Plant Oils; Oils; Lipids; Plant Preparations; Biological Products; Complex Mixtures

Study Officials

• Anil Pillai, M.D.

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ASSOC PROFESSOR - Radiology

Study Record Dates

• First Submitted: July 1, 2020
• First Posted: July 7, 2020
• Study Start: November 4, 2022
• Primary Completion: September 23, 2025
• Study Completion: September 23, 2025
• Last Updated: January 8, 2026

Record last verified: 2026-01

Locations

US (1)