Using mitochondrial DNA in blood to monitor liver cancer recurrence
Evaluation of Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Minimal Residual Disease (MRD) Assessment and Recurrence Monitoring in Hepatocellular Carcinoma (HCC)
This study is testing if looking at mitochondrial DNA in the blood can help doctors track liver cancer recurrence in patients after treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 50 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Trial ID | NCT06653062 on ClinicalTrials.gov |
What this trial studies
This observational study aims to evaluate the effectiveness of circulating tumor mitochondrial DNA (ct-mtDNA) as a biomarker for assessing minimal residual disease (MRD) and monitoring recurrence in patients with hepatocellular carcinoma (HCC). Conducted at Tongji Hospital in Wuhan, China, the study will collect and analyze plasma samples from HCC patients to detect mitochondrial mutations before and after treatment. The primary goal is to determine how MRD status impacts progression-free survival, while secondary objectives include examining the correlation between MRD markers and treatment outcomes. The study hypothesizes that ct-mtDNA dynamics are linked to recurrence risk and overall survival in HCC patients.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with hepatocellular carcinoma who meet specific inclusion criteria and have measurable lesions.
Not a fit: Patients with other active tumors or insufficient tumor tissue for MRD detection may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a novel method for early detection of liver cancer recurrence, potentially improving patient outcomes.
How similar studies have performed: While the use of ct-mtDNA as a biomarker is a relatively novel approach, similar studies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Wuhan, Hubei
- Tongji Hospital — Wuhan, Hubei, China (Recruiting)
Study contacts
- Study coordinator: Ze-yang Ding, M.D.
- Email: zyding@tjh.tjmu.edu.cn
- Phone: +8613407156200
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.