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Clinical Trials in South Korea / NCT07452432
Recruiting Observational

Korean Prospective Upper Tract Urothelial Carcinoma Cohort

NCT07452432 · tracked via the Priya Life Science South Korea tracker
Sponsor
Samsung Medical Center
Phase
Observational
Started
2026-01-01
Last updated
2026-03-05

Condition(s) studied

Urothelial Carcinoma (UC)

Investigational drug(s) / intervention(s)

Peripheral blood collection for ctDNA analysis

Peripheral blood collection for ctDNA analysis: 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.

Study 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

Sex
ALL
Min age
19 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Recurrence-free survival (RFS) — From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)
    Recurrence is defined as radiographic and/or pathologic evidence of local recurrence, regional nodal recurrence, distant metastasis, or intravesical recurrence documented during routine follow-up.

Trial sites (1)

FacilityCityRegionStatus
Samsung Medical Center Seoul South Korea Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07452432 on ClinicalTrials.gov ↗ ← All trials in South Korea