Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Hepatocellular Carcinoma Recurrence Surveillance
Evaluation of Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Minimal Residual Disease (MRD) Assessment and Recurrence Monitoring in Hepatocellular Carcinoma (HCC)
Tongji Hospital
50 participants
Nov 18, 2024
OBSERVATIONAL
Conditions
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
Inclusion Criteria5
- 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 Criteria2
- Patients with other active tumors or severe complications;
- Insufficient tumor tissue for MRD detection.
Interventions
Targeted Analysis of Mitochondrial Mutations: Unlike many interventions that may focus on nuclear DNA or general tumor markers, this intervention specifically analyzes mutations within the mitochondrial genome. This focus on mtDNA is based on evidence suggesting that mtDNA mutations are more frequent and may serve as more sensitive indicators of minimal residual disease (MRD) in cancer patients. Liquid Biopsy Approach: The intervention utilizes a liquid biopsy technique, which involves the collection and analysis of peripheral blood samples to detect circulating tumor DNA (ctDNA). This non-invasive method contrasts with traditional tissue biopsy interventions, offering a less intrusive approach to monitor disease progression and recurrence.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT06653062