NCT07452432 Korean Prospective Upper Tract Urothelial Carcinoma Cohort
| NCT ID | NCT07452432 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Samsung Medical Center |
| Condition | Urothelial Carcinoma (UC) |
| Study Type | OBSERVATIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-01-01 |
| Primary Completion | 2030-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 300 participants in total. It began in 2026-01-01 with a primary completion date of 2030-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07452432 clinical trial?
This trial is open to participants of all sexes, aged 19 Years or older, studying Urothelial Carcinoma (UC). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07452432 currently recruiting?
Yes, NCT07452432 is actively recruiting participants. Contact the research team at jiwoong082.yu@samsung.com for enrollment information.
Where is the NCT07452432 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT07452432 clinical trial?
NCT07452432 is sponsored by Samsung Medical Center. The trial plans to enroll 300 participants.