Actively Recruiting
Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma
Led by Samsung Medical Center · Updated on 2026-03-05
300
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a single-center, prospective, non-interventional observational cohort study to monitor recurrence in Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (UTUC). This study aims to combine clinical and molecular data to support future research and develop models to predict recurrence and survival outcomes in UTUC. The study focuses on adult patients scheduled for neoadjuvant chemotherapy followed by radical nephroureterectomy, addressing a gap in prospective data particularly in Asian populations. Participants will provide peripheral blood samples for circulating tumor DNA (ctDNA) analysis before starting neoadjuvant chemotherapy and once between one to six months after surgery. The study does not involve investigational drugs; all treatments and evaluations follow standard clinical practice. Clinical, imaging, pathological, and longitudinal follow-up data will be collected to monitor recurrence and survival. Participants will be followed for up to five years, with data collected on recurrence-free survival, overall survival, cancer-specific survival, and ctDNA positivity rates. Researchers will gather demographic, clinical, treatment, and outcome data, including imaging and pathology results, to support long-term monitoring and future precision oncology research. The study allows ongoing observation without intervention beyond standard care.
CONDITIONS
Brief Title
Korean Prospective Upper Tract Urothelial Carcinoma Cohort
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older
- 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
You will not qualify if you...
- Evidence of distant metastasis (M1)
- Contraindication to cisplatin-based chemotherapy
- Uncontrolled infection or severe comorbid medical condition
- Pregnancy or breastfeeding
- Any condition that makes participation inappropriate based on investigator's judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Up to 5 years
Participants undergo peripheral blood collection for circulating tumor DNA (ctDNA) analysis before starting neoadjuvant chemotherapy and again between 1 to 6 months after surgery. Clinical, imaging, pathological, and longitudinal data are collected to monitor recurrence and survival according to standard clinical practice without additional interventions.
2 blood collection visits (in-person) and regular clinical assessments as per routine care
Trial Site Locations
Total: 1 location
1
Samsung Medical Center
Seoul, South Korea
Actively Recruiting
Research Team
J
Jiwoong Yu, MD
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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