Korean Prospective Upper Tract Urothelial Carcinoma Cohort

February 28, 2026 updated by: Byong Chang Jeong, Samsung Medical Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence-free survival (RFS)
Time Frame: 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.
From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)

Secondary Outcome Measures

Outcome Measure
Time Frame
Overall survival (OS)
Time Frame: From date of surgery to death from any cause or last follow-up (up to 5 years)
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)
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
Baseline (pre-NAC) and postoperative 1-6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2026

Primary Completion (Estimated)

January 1, 2030

Study Completion (Estimated)

June 1, 2030

Study Registration Dates

First Submitted

February 28, 2026

First Submitted That Met QC Criteria

February 28, 2026

First Posted (Actual)

March 5, 2026

Study Record Updates

Last Update Posted (Actual)

March 5, 2026

Last Update Submitted That Met QC Criteria

February 28, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SMC2025-12-074-002

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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