Korean Prospective Upper Tract Urothelial Carcinoma Cohort

NCT07452432 | Recruiting

• 1 other identifier: SMC2025-12-074-002
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Urothelial Carcinoma (UC)

Outcome Measures

Primary Outcomes (1)

• Recurrence-free survival (RFS)

  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.

  From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)

Secondary Outcomes (3)

• 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

Study Arms (1)

High-grade non-metastatic UTUC prospective cohort

Adult patients (≥19 years) with high-grade non-metastatic upper tract urothelial carcinoma (cT2-T4, cN0-1, M0) who are planned for neoadjuvant chemotherapy followed by radical nephroureterectomy will be enrolled in this single-center prospective observational cohort. Peripheral blood will be collected for ctDNA analysis prior to neoadjuvant chemotherapy and once between 1-6 months after surgery. Clinical, imaging, pathological, and longitudinal follow-up data will be prospectively collected for recurrence and survival monitoring.

Other: Peripheral blood collection for ctDNA analysis

Interventions

Peripheral blood collection for ctDNA analysis OTHER

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.

High-grade non-metastatic UTUC prospective cohort

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult Korean patients with high-grade non-metastatic upper tract urothelial carcinoma (cT2-T4, cN0-1, M0) who are candidates for neoadjuvant chemotherapy followed by radical nephroureterectomy at a single tertiary referral center.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Samsung Medical Center: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral blood samples will be collected at two predefined time points: prior to initiation of neoadjuvant chemotherapy and once between 1-6 months after radical nephroureterectomy. Plasma-derived circulating tumor DNA (ctDNA) will be analyzed using whole-genome sequencing-based copy number variation assessment to estimate tumor fraction. Biospecimens are collected for research purposes only and will not be used to guide clinical decision-making. Samples may be stored for future translational analyses related to recurrence monitoring and molecular characterization of upper tract urothelial carcinoma.

MeSH Terms

Conditions

Carcinoma, Transitional Cell

Condition Hierarchy (Ancestors)

Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Jiwoong Yu, MD

CONTACT

+82234103559; jiwoong082.yu@samsung.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 5 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: February 28, 2026
• First Posted: March 5, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2030
• Study Completion (Estimated): June 1, 2030
• Last Updated: March 5, 2026

Record last verified: 2026-02

Locations

KR (1)