Urothelial Carcinoma (UC)
Conditions
Brief 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.
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
OTHERPeripheral 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.
Sponsors
Samsung Medical Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame |
|---|---|
| Overall survival (OS) | From date of surgery to death from any cause or last follow-up (up to 5 years) |
| Cancer-specific survival (CSS) | From date of surgery to death due to UTUC or last follow-up (up to 5 years) |
| ctDNA positivity rate at each time point | Baseline (pre-NAC) and postoperative 1-6 months |
Countries
South Korea
Contacts
CONTACTJiwoong Yu, MD
Outcome results
None listed