NCT06554730撤回不适用
Non-interventional Post-authorization Study of Belzutifan in Adult Patients With Von Hippel-Lindau Disease-associated Renal Cell Carcinoma, Pancreatic Neuroendocrine Tumor and/or Central Nervous System Hemangioblastoma (MK-6482-026)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 入组人数
- 100
- 主要终点
- Procedure
研究概览
简要总结
This is a prospective observational cohort study evaluating the effectiveness and safety of belzutifan treatment in routine clinical practice.
This study has been registered and will be maintained through close out on the RWD Catalogues Observational Registry - https://catalogues.ema.europa.eu/ under the EU PAS number:
EUPAS108114
详细描述
Primary Objective
- Among new users of belzutifan with VHL disease-associated RCC, to describe the proportion of patients who undergo at least one renal tumor reductive surgery (e.g., nephrectomy) or locally directed therapy (e.g., radiofrequency ablation).
- Among new users of belzutifan with VHL disease-associated CNS hemangioblastoma, to describe the proportion of patients who undergo at least one CNS tumor reductive surgery (e.g., craniectomy) or locally directed therapy (e.g., radiation therapy).
Secondary Objectives
Among all new users of belzutifan to describe:
- Proportion of patients with treatment emergent SAEs, including the nature of these events.
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
- •Greater than or equal to 18 years of age
- •Diagnosed with VHL disease based on a germline test or clinical diagnosis
- •A decision has been made by the treating physician (at his/her discrestion) to intitate the first belzutifan treatment (i.e., belzutifan 'new users'), within the prescribing conditions of the approved product label
- •Signed informed consent prior to or withing 30 days after the first inititaion of belzutifan
排除标准
- •Anti-cancer systemic therapy within 2 weeks prior to the index date
- •Unable to consent to participate in the study
- •History of VHL disease-related metastasis or advanced cancer
结局指标
主要结局
Procedure
时间窗: Through study completion
Proportion of patients who undergo surgery or other tumor reductive procedure.
次要结局
未报告次要终点
研究者
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