NCT07465458尚未招募不适用
Radiofrequency Ablation Multicenter Observational Study in Renal Oncology Patients
Humanitas Hospital, Italy10 个研究点 分布在 2 个国家目标入组 226 人开始时间: 2026年3月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 226
- 试验地点
- 10
- 主要终点
- Technical success
研究概览
简要总结
This observational study is designed to expand the current database available in the literature and the existing knowledge on the outcomes and safety of radiofrequency ablation (RFA) for the treatment of primary renal cell carcinomas in stage T1a. All interventions and subsequent follow-ups are clinical decisions are independent of the study, given its observational nature.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient selection criteria will be those typically established by each participating center t with T1a primary renal tumors for which a Multidisciplinary Tumor Board has indicated as candidates for treatment with radiofrequency ablation.I
- •Inclusion Criteria:
- •Age ≥18 years
- •Signed informed consent approved by the Ethics Committee prior to the ablation procedure.
- •RCC in stage T1a (size <4 cm), single or multiple, histologically demonstrated by percutaneous biopsy before or within 30 days prior to ablation
- •Absence of comorbidities that contraindicate treatment
- •Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-2 at baseline screening.
排除标准
- •No specific exclusion criteria are established for this clinical registry due to its observational nature. Each center will apply its own criteria according to its routine clinical practice.
结局指标
主要结局
Technical success
时间窗: up to 2 months post-procedure
ablation zone evaluated post-ablation
Technical efficacy
时间窗: up to 12 months
Abscence of tumor recurrence within the margin of the ablation zone or viable residual tumor on follow-up imaging
次要结局
- Local Tumor Progression (LTP)(up to 12 months)
- Cancer Specific Survival (CSS)(up to 12 months)
- Patient reported outcomes(up to 12 months)
- Ablation related complications(up to 12 months)
- TRIFECA achievement(up to 12 months)
- Treatment efficacy by tumor histotypes(up to 12 months)
- Distant metastasis-free survival (DMFS)(up to 12 months)
- Overall Survival(up to 12 months)
- Preserved renal function(up to 12 months)
- Retreatment rate(up to 12 months)
- Time to local tumor progression ( TT-LPP)(up to 12 months)
- Cost-effectiveness analysis(up to 12 months)
研究者
Vittorio Pedicini
Principal Investigator
Humanitas Hospital, Italy
研究点 (10)
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