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NCT07303712Recruiting

Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

Palo Alto Veterans Institute for Research

Start Date

8/1/2024

Completion Date

12/1/2026

Summary

The purpose of this study is to determine if baseline liquid biopsy assays (CTC and cf-DNA) as well as single circulating tumor cell-DNA (sCTC DNA) dynamics in the early post-treatment period can predict subsequent treatment response to Y-90 radioembolization in patients with hepatocellular carcinoma (HCC).

Detailed Description

Study Aims and Objectives: 1. Assess the detection rate of CTC and cfDNA-based mutations and the distribution of molecular features of HCC prior to Y90 across BCLC A-C stages. 2. Determine CTC and cfDNA predictors at baseline that predict Y90 treatment response at 6-9 months. 3. Determine temporal changes in CTC and cfDNA mutations from baseline over 6-9 month course post Y90. 4. Determine if CTC mean distribution, sCTCDNA, and/or cfDNA mutational dynamic changes are predictive of treatment response at 6-9 months. 5. Assess radiomic and liquid biopsy signatures associated with outcome 6. Compare predictive outcome models using liquid biopsy data, imaging data, or a combination (multiomic data)

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: 1. Age \> or = 18 years 2. HCC confirmed on imaging, BCLC stage 0, A, B, or C 3. Transarterial Y90 radioembolization approved by multidisciplinary tumor board - Exclusion Criteria: 1. Not eligible for Y90 procedure 2. Prior surgery or ablation on indicated tumors 3. Patient unable to complete the follow up visits required for clinical care or research -

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Conditions

Hepatocellular Carcinoma (HCC)

Locations

VA Palo Alto Health Care System

Palo Alto, California 94304

United States