Actively Recruiting

Age: 18Years +
All Genders
ID06653062

Study of Circulating Tumor Mitochondrial DNA as a Biomarker for Detecting Minimal Residual Disease and Monitoring Recurrence in Hepatocellular Carcinoma

Led by Tongji Hospital · Updated on 2024-12-30

50

Participants Needed

1

Research Sites

184 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Hepatocellular carcinoma (HCC) is a common cause of cancer death worldwide, especially in China, where late diagnosis and high recurrence rates lead to poor outcomes. This study focuses on evaluating circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker to detect minimal residual disease (MRD) and monitor recurrence in patients with HCC. Researchers aim to understand how tumor mitochondrial mutations in plasma relate to the risk of recurrence and progression-free survival in these patients. The study involves collecting and analyzing plasma samples from HCC patients to identify mitochondrial DNA mutations before and after treatment using a liquid biopsy approach. This method is non-invasive and targets mitochondrial mutations specifically, which may be more sensitive indicators of MRD compared to other tumor markers. The study is observational and conducted at a single center under the Chinese Cooperative Group of Liver Cancer. Participants will be regularly assessed for MRD status, with follow-up evaluations up to two years after treatment to track progression-free survival. Researchers will measure the impact of MRD on disease progression, the relationship between residual tumor molecular burden and survival, and whether MRD detection can predict recurrence earlier than traditional markers or imaging. The study aims to improve personalized management and long-term outcomes for patients with HCC.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients with hepatocellular carcinoma (HCC)
  • Diagnosis of HCC according to American or European liver disease guidelines
  • At least one measurable lesion based on RECIST v1.1 or mRESIST criteria
  • Expected survival time of 12 weeks or more
  • Signed informed consent and ability to follow study procedures
Not Eligible

You will not qualify if you...

  • Patients with other active tumors or severe complications
  • Insufficient tumor tissue for MRD detection

AI-Screening

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Trial Site Locations

Total: 1 location

1

Tongji Hospital

Wuhan, Hubei, China, 430030

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Research Team

Z

Ze-yang Ding, M.D.

H

Han Gao

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

0

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