Liquid Biopsy for Hepatocellular Carcinoma Molecular Characterization After Y90

NCT ID: NCT07303712

Last Updated: 2025-12-26

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

RECRUITING

Total Enrollment

12 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-08-01

Study Completion Date

2026-12-01

Brief Summary

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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

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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)

Conditions

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Hepatocellular Carcinoma (HCC)

Keywords

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Circulating tumor cell (CTC) y90

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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 -
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Palo Alto Veterans Institute for Research

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sirish Kishore, MD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System

Locations

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VA Palo Alto Health Care System

Palo Alto, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Sirish Kishore, MD

Role: CONTACT

Phone: 650-493-5000

Email: [email protected]

Luisa Manfredi, MPH

Role: CONTACT

Phone: 650-493-5000

Email: [email protected]

Facility Contacts

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Sirish Kishore, MD

Role: primary

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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KIS0003ARG

Identifier Type: -

Identifier Source: org_study_id