Identify Proteomic Biomarkers for Outcome Prediction of Locoregional Treatments for HCC

NCT ID: NCT04459468

Last Updated: 2026-01-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

17 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-11-04

Study Completion Date

2025-09-23

Brief Summary

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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

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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.

Conditions

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Hepatocellular Carcinoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Lipiodol

Intervention Type DRUG

Lipiodol TACE procedure

Healthy controls

Healthy controls from public database

No interventions assigned to this group

HCC patients

HCC patients will be used for biomarker validation.

No interventions assigned to this group

Interventions

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Lipiodol

Lipiodol TACE procedure

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Texas Southwestern Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Anil Pillai

ASSOC PROFESSOR - Radiology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Anil Pillai, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Texas Southwestern Medical Center

Locations

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UT Southwestern Medical Center

Dallas, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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STU-2019-1758

Identifier Type: -

Identifier Source: org_study_id

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