Using mitochondrial DNA in blood to monitor biliary tract cancer recurrence
Official title: 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)
Run by Tongji Hospital · NCT06653127 · Data updated 2026-11-12
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 |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Tongji Hospital Academic / other |
| Locations | 1 site (Wuhan, Hubei) |
| Status | Recruiting |
| Started | November 13, 2024 |
| Main results expected | October 31, 2027 |
| Study ends | June 1, 2028 |
| Registry record updated | December 30, 2024 |
| Trial ID | NCT06653127 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include patients with histologically confirmed biliary tract cancer who are expected to survive for at least 12 weeks.
✕Probably not a fit
Patients with other active tumors or severe complications may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
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.
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 gone: While the use of ct-mtDNA as a biomarker is a novel approach, similar studies in other cancer types have shown promising results.
Who can join: the full rules
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 it's running
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Tongji Hospital
Wuhan, Hubei, China Recruiting
Study contacts
- Study coordinator: Ze-yang Ding, M.D.
- Email: zyding@tjh.tjmu.edu.cn
- Phone: +8613407156200
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.