Using ctDNA to predict recurrence in biliary tract cancers after surgery
ctDNA Detection of MRD in Predicting Postoperative Recurrence in Biliary Tract Cancers：A Multicenter Prospective Trial
This study tests if measuring circulating tumor DNA (ctDNA) after surgery can help predict if biliary tract cancer will come back, compared to standard methods.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | The First Affiliated Hospital with Nanjing Medical University Academic / other |
| Locations | 1 site (Nanjing, Jiangsu) |
| Trial ID | NCT05743959 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of circulating tumor DNA (ctDNA) in detecting minimal residual disease (MRD) in patients with biliary tract cancers following curative surgery. It aims to establish a correlation between postoperative ctDNA levels and patient prognosis, assessing whether ctDNA can more accurately predict recurrence compared to traditional methods. The study will involve patients diagnosed with biliary tract cancer who are undergoing radical surgery, with a focus on monitoring their ctDNA status postoperatively.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stage I-III biliary tract cancer who are undergoing radical surgery.
Not a fit: Patients with recurrent biliary tract tumors or those not undergoing radical surgery may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved prediction of cancer recurrence, allowing for timely interventions and better patient outcomes.
How similar studies have performed: While ctDNA has shown promise in monitoring other solid tumors, its application in biliary tract cancers is less explored, making this study a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Male or female ≥ 18 years of age on the day of signing informed consent. 2. Clinically diagnosed as BTC before surgery and confirmed by pathology after surgery. 3. Stage I-III tumor according to the UICC/AJCC TNM staging system (8th edition in 2017), meeting the indications for radical surgery and are planned to undergo radical treatment. Those who do not undergo radical surgery will be excluded. 4. Patients must have a performance status of ≤1 on the ECOG Performance Scale. 5. Patients must have survival of \> 6 months after surgery 6. Serological tumor indicators (CEA, CA19-9) and imaging data ( CT and/or MRI, PET-CT) were complete. 7. Blood biochemical indicators meet surgical standards 8. Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study. Exclusion Criteria: 1. Patients with recurrent biliary tract tumors 2. Patients with hepatobiliary mixed tumors 3. Patients with malignant tumors of other organs that have not been cured before. 4. History of organ transplant or allogeneic stem cell transplant 5. Patients with severe infections that are active or poorly controlled clinically 6. patients who are cognitively impaired or with known psychiatric disorders, and/or substance abuse 7. pregnant or lactating women 8. Failed to sign informed consent 9. Other conditions that researchers judged inappropriate for inclusion
Where this trial is running
Nanjing, Jiangsu
- The First Affiliated Hospital with NanJing Medical University — Nanjing, Jiangsu, China (Recruiting)
Study contacts
- Principal investigator: Xiangcheng Li, PhD — The First Affiliated Hospital with Nanjing Medical University
- Study coordinator: Xiangcheng Li, PhD
- Email: drlixc@163.com
- Phone: +8618951999088
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.