Korean cohort for monitoring high-grade upper tract urothelial carcinoma
Official title: Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma
Run by Samsung Medical Center · NCT07452432 · Data updated 2026-11-12
This project will test whether blood-based ctDNA taken before chemotherapy and again after surgery can help monitor recurrence risk in Korean adults with high-grade, non-metastatic upper tract urothelial carcinoma who are planned for neoadjuvant chemotherapy and radical nephroureterectomy.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 19 Years and up |
| Sex | All |
| Enrollment | 300 (estimated) |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Status | Recruiting |
| Started | January 1, 2026 |
| Main results expected | January 1, 2030 |
| Study ends | June 1, 2030 |
| Registry record updated | March 5, 2026 |
| Trial ID | NCT07452432 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥19 years) in Korea with histologically confirmed high-grade UTUC staged cT2-T4, cN0-1, M0, ECOG 0-1, who are planned to receive neoadjuvant chemotherapy followed by radical nephroureterectomy and can give informed consent.
✕Probably not a fit
Patients with distant metastatic disease (M1), those not receiving the planned neoadjuvant chemotherapy and surgery, pregnant or breastfeeding individuals, or those with contraindications to cisplatin are unlikely to benefit from this cohort.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This single-center, prospective, non-interventional cohort at Samsung Medical Center will enroll adults with high-grade, non-metastatic upper tract urothelial carcinoma who are planned for neoadjuvant chemotherapy followed by radical nephroureterectomy. Blood samples for circulating tumor DNA (ctDNA) will be collected before starting chemotherapy and once between one and six months after surgery, while clinical, imaging, pathological, treatment, and outcome data are recorded. Follow-up will occur according to standard clinical practice with data collected prospectively for up to five years and no protocol-mandated interventions. The assembled clinical and molecular dataset is intended to serve as a platform for recurrence prediction modeling and future translational research in UTUC.
Why it matters
Potential benefit: If successful, this approach could enable earlier detection of minimal residual disease and recurrence, supporting more personalized surveillance and treatment decisions.
How similar studies have gone: Prior ctDNA studies in bladder urothelial carcinoma have shown promise for minimal residual disease detection and early recurrence monitoring, but prospective data specifically for UTUC—especially in Asian populations—remain limited.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age ≥ 19 years Histologically confirmed high-grade upper tract urothelial carcinoma (renal pelvis and/or ureter) Clinical stage cT2-T4, cN0-1, M0 Planned neoadjuvant chemotherapy followed by radical nephroureterectomy ECOG performance status 0-1 Adequate hematologic, hepatic, and renal function Ability to provide written informed consent Exclusion Criteria: * Evidence of distant metastasis (M1) Contraindication to cisplatin-based chemotherapy Uncontrolled infection or severe comorbid medical condition Pregnancy or breastfeeding Any condition that, in the investigator's judgment, makes participation inappropriate
Where it's running
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Samsung Medical Center
Seoul, South Korea Recruiting
Study contacts
- Study coordinator: Jiwoong Yu, MD
- Email: jiwoong082.yu@samsung.com
- Phone: +82234103559
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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.