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临床试验/NCT04459468
NCT04459468已完成不适用

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

University of Texas Southwestern Medical Center1 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2022年11月4日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
17
试验地点
1
主要终点
Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

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.

干预措施: Lipiodol (Drug)

Healthy controls

Healthy controls from public database

HCC patients

HCC patients will be used for biomarker validation.

结局指标

主要结局

Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients

时间窗: 2 years

X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP.

次要结局

  • Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients.(2 years)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Anil Pillai

ASSOC PROFESSOR - Radiology

University of Texas Southwestern Medical Center

研究点 (1)

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