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Recruiting NCT06653062

Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Hepatocellular Carcinoma Recurrence Surveillance

Trial Parameters

Condition Hepatocellular Carcinoma (HCC)
Sponsor Tongji Hospital
Study Type OBSERVATIONAL
Phase N/A
Enrollment 50
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2024-11-18
Completion 2027-12-31
Interventions
Plasma and Tumor Tissue Mitochondrial DNA (mtDNA) Mutation Analysis

Brief Summary

This is a prospective, observational, single-center study. The purpose of this study is to evaluate the efficacy of circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker for minimal residual disease (MRD) assessment and recurrence monitoring in patients with hepatocellular carcinoma.

Eligibility Criteria

Inclusion Criteria: * Patients with hepatocellular carcinoma (HCC); * Diagnosis of HCC is according to the American Association for the Study of Liver Diseases or European Association for the Study of the Liver guidelines of HCC management; * At least one measurable lesion according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 or mRESIST criteria.; * Expected survival time of 12 weeks or more; * Signed informed consent form and ability to comply with the study visits and related procedures as stipulated in the protocol. Exclusion Criteria: * Patients with other active tumors or severe complications; * Insufficient tumor tissue for MRD detection.

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