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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Republic of Korea
Samsung Medical Center
RECRUITING
Seoul
Contact Information
Primary
Jiwoong Yu, MD
jiwoong082.yu@samsung.com
+82234103559
Time Frame
Start Date: 2026-01-01
Estimated Completion Date: 2030-06-01
Participants
Target number of participants: 300
Treatments
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.
Sponsors
Leads: Samsung Medical Center

This content was sourced from clinicaltrials.gov

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