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Recruiting NCT07452432

Korean Prospective Upper Tract Urothelial Carcinoma Cohort

— Observational Urothelial Carcinoma (UC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Peripheral blood collection for ctDNA analysis.
Who it may be relevant to
Registry conditions: Urothelial Carcinoma (UC). Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma

Overview

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.

Detailed description

Upper tract urothelial carcinoma (UTUC) is an aggressive malignancy with a high rate of recurrence and metastatic progression following definitive surgery. Although circulating tumor DNA (ctDNA) has shown promise for minimal residual disease detection and early recurrence monitoring in urothelial carcinoma, prospective data in UTUC, particularly in Asian populations, remain limited.

This single-center, prospective, non-interventional observational cohort study aims to establish a structured recurrence monitoring cohort in Korean patients with high-grade non-metastatic UTUC. Adult patients with clinical stage cT2-T4, cN0-1, M0 disease who are planned for neoadjuvant chemotherapy followed by radical nephroureterectomy will be enrolled after providing written informed consent.

ctDNA blood samples will be collected prior to initiation of neoadjuvant chemotherapy and once between 1-6 months following surgery. All treatment decisions, imaging evaluations, and follow-up assessments will be conducted according to standard clinical practice without protocol-mandated interventions.

Demographic, clinical, imaging, pathological, treatment, and longitudinal outcome data will be prospectively collected for up to five years. The study is designed as a cohort-establishment platform and does not test a predefined interventional hypothesis. The accumulated data will serve as a foundation for future recurrence prediction modeling and precision oncology research in UTUC.

Interventions

  • Other 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.

Primary outcome measures

  • Recurrence-free survival (RFS) [Time frame: From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)]
Secondary outcome measures (3)
  • Overall survival (OS) [Time frame: From date of surgery to death from any cause or last follow-up (up to 5 years)]
  • Cancer-specific survival (CSS) [Time frame: From date of surgery to death due to UTUC or last follow-up (up to 5 years)]
  • ctDNA positivity rate at each time point [Time frame: Baseline (pre-NAC) and postoperative 1-6 months]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Samsung Medical Center — Seoul

Identifiers

NCT: NCT07452432 · SMC2025-12-074-002

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗