Using mitochondrial DNA in blood to monitor biliary tract cancer recurrence
Evaluation of Circulating Tumor Mitochondrial DNA (ct-mtDNA) As a Biomarker for Minimal Residual Disease (MRD) Assessment and Recurrence Monitoring in Post-treatment Biliary Tract Cancer （BTC）
This study is testing if checking for changes in mitochondrial DNA in blood can help doctors see if biliary tract cancer comes back 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 | NCT06653127 on ClinicalTrials.gov |
What this trial studies
This prospective, observational study aims to evaluate the effectiveness of circulating tumor mitochondrial DNA (ct-mtDNA) in plasma as a biomarker for minimal residual disease (MRD) assessment and recurrence monitoring in patients with biliary tract cancer. Conducted at Tongji Hospital in Wuhan, the study will analyze plasma samples from patients with confirmed biliary tract cancer before and after treatment to detect mutations in mitochondrial DNA. The primary goal is to determine how MRD status impacts progression-free survival, while secondary objectives will explore the relationship between treatment and MRD markers.
Who should consider this trial
Good fit: Ideal candidates include patients with histologically confirmed biliary tract cancer who are expected to survive for at least 12 weeks.
Not a fit: Patients with other active tumors or severe complications may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a non-invasive method for early detection of cancer recurrence in biliary tract cancer patients.
How similar studies have performed: While the use of ct-mtDNA as a biomarker is a novel approach, similar studies in other cancer types have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Histologically confirmed biliary tract cancer (BTC); * 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.