Clinical trial · Observational
Korean Prospective Upper Tract Urothelial Carcinoma Cohort
Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Urothelial Carcinoma (UC) | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.85 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Peripheral blood collection for ctDNA analysis | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- High-grade non-metastatic UTUC prospective cohort
- description
- 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.
- interventionNames
- Other: Peripheral blood collection for ctDNA analysis
Primary outcomes (1)
- measure
- Recurrence-free survival (RFS)
- timeFrame
- From date of radical nephroureterectomy to first documented recurrence or last follow-up (up to 5 years)
- description
- 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 outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available