Hepatocellular Carcinoma
Conditions
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.
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, 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.
Interventions
Lipiodol TACE procedure
Sponsors
Study design
Eligibility
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for overall survival in hepatocellular carcinoma patients | 2 years | X-aptamer identified biomarker to predictability for tumor response rate after treatment with Lipoidol TACE compared to standard of care biomarkers-AFP. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Predictive accuracy of Proteomic biomarker(s) measured with bead-based X-aptamer library for Progression free survival in Hepatocellular carcinoma patients. | 2 years | X-aptamer identified biomarker to predict overall survival after treatment with Lipoidol TACE . |
Countries
United States