Prospective Establishment of a Recurrence Monitoring Cohort in Korean Patients With Upper Tract Urothelial Carcinoma
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Recurrence-free survival (RFS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
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.
干预措施: Peripheral blood collection for ctDNA analysis (Other)
结局指标
主要结局
Recurrence-free survival (RFS)
时间窗: 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.
次要结局
- ctDNA positivity rate at each time point(Baseline (pre-NAC) and postoperative 1-6 months)
- 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))
研究者
Byong Chang Jeong
Professor
Samsung Medical Center