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Recruiting NCT06382103

Biomarkers and Molecular Mechanism Study of Hepatocellular Carcinoma After Radical Resection and Conversion Therapy

Observational Hepatocellular Carcinoma

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: ctDNA monitoring, Plasma proteomic analysis.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

Blood samples will be tested to identify circulating tumor DNA and plasma protein levels to potentially improve prediction of long term prognosis and guide treatment options of patients with hepatocellular carcinoma underwent surgical resection.

Interventions

  • Diagnostic test ctDNA monitoring
    The ctDNA level will be measured using tumor-informed (Signatera platform) and tumor-naived (fragmentomes measurement) assay.
  • Diagnostic test Plasma proteomic analysis
    plasma protein level will be measured via Proximity Extension Assay and LC-MS based proteomic analysis

Primary outcome measures

  • Correlation between ctDNA level and recurrence-free survival (RFS) [Time frame: 1 years]
  • Correlation between specific plasma protein expression level and recurrence-free survival (RFS) [Time frame: 1 years]
Secondary outcome measures (1)
  • Correlation between tumor mutation numbers and recurrence-free survival (RFS) [Time frame: 1 years]

Eligibility criteria

Inclusion criteria

  • Patients with a first diagnosis of HCC.
  • Patients with HCC who are to undergo surgical treatment, with or without neoadjuvant therapy.
  • Ability to obtain tissue sample for ctDNA analysis and detectable baseline ctDNA level.

Exclusion criteria

  • Patients with secondary liver cancer, or intrahepatic cholangiocarcinoma.
  • Any other concurrent malignancy.
  • History of organ transplant or hepatic encephalopathy.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Other

Study locations

China · 1 center
  • Zhongshan Hospital Fudan University — Shanghai

Identifiers

NCT: NCT06382103 · B2024-108R

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗