Korean Prospective Upper Tract Urothelial Carcinoma Cohort
Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma
Samsung Medical Center
300 participants
Jan 1, 2026
OBSERVATIONAL
Conditions
Summary
This is a single-center, prospective, non-interventional observational cohort study designed to establish a structured recurrence monitoring platform in Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (UTUC). Eligible adult patients scheduled to receive neoadjuvant chemotherapy followed by radical nephroureterectomy will undergo circulating tumor DNA (ctDNA) sampling prior to chemotherapy initiation and once between 1-6 months after surgery. Clinical, imaging, pathological, and longitudinal follow-up data will be prospectively collected to enable long-term monitoring of recurrence and survival outcomes. The primary objective is to establish a prospective cohort integrating clinical and molecular data to support future translational research and recurrence prediction modeling in UTUC.
Eligibility
Inclusion Criteria7
- 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 Criteria5
- 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
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Interventions
Peripheral blood samples (20-30 mL) will be collected prior to neoadjuvant chemotherapy initiation and once between 1-6 months after surgery for circulating tumor DNA (ctDNA) analysis. No investigational drug or device is administered. All oncologic treatments are conducted according to standard clinical practice.
Locations(1)
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NCT07452432