Korean cohort for monitoring high-grade upper tract urothelial carcinoma
Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma
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 |
|---|---|
| Enrollment | 300 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Samsung Medical Center Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Seoul) |
| Trial ID | NCT07452432 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Seoul
- Samsung Medical Center — Seoul, South Korea (Recruiting)
Study contacts
- Study coordinator: Jiwoong Yu, MD
- Email: jiwoong082.yu@samsung.com
- Phone: +82234103559
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.