NCT04472663已完成不适用
Patient Reported Outcomes And Treatment Experiences In Renal Cell Carcinoma (ONE-RCC)
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 5 人开始时间: 2020年7月6日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
The purpose of this observational study is to collect contemporary real-world treatment patterns, clinical outcomes, humanistic burden (including patient-reported disease-specific Health-related Quality of Life (HRQoL), and treatment- related adverse events (AEs) or adverse reactions (ARs) among Advanced Renal Cell Carcinoma (aRCC) patients initiating first-line systemic therapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •Primary diagnosis of aRCC (advanced Renal Cell Carcinoma) or metastatic RCC
- •Medical history must be available from date of aRCC diagnosis
- •Initiated 1LOT between April 2018 - March 2020
- •Primary diagnosis of aRCC (not amenable to curative surgery or radiation therapy/ AJCC Stage III unresectable) or metastatic RCC (AJCC Stage IV).
- •Medical history must be available from date of aRCC diagnosis.
- •Initiate 1LOT.
排除标准
- •Currently enrolled in a clinical trial for treatment of aRCC
- •Any prior malignancy active within the previous 3 year, except for locally curable cancers that have been cured
- •Any prior systemic therapy for aRCC, with the exception of neoadjuvant or adjuvant therapy (Cohort 2 only)
- •Other protocol-defined inclusion/exclusion criteria apply
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to 36 months
Disease-related symptoms as measured by change from baseline in FKSI-DRS
时间窗: Up to 36 months
次要结局
- Demographic characteristics of aRCC patients as measured by continuous statistics: Family history of RCC(Up to 36 months)
- Time to therapy initiation of LOT(Up to 36 months)
- Demographic characteristics of aRCC patients as measured by continuous statistics: Age(Up to 36 months)
- Demographic characteristics of aRCC patients as measured by categorical statistics: Race/ethnicity(Up to 36 months)
- Rationale for therapy selection(Up to 36 months)
- Drug use characteristics including dosing regimens : Frequency of administration(Up to 36 months)
- Drug use characteristics including dosing regimens : Number of cycles planned and administered(Up to 36 months)
- Demographic characteristics of aRCC patients as measured by continuous statistics: Height(Up to 36 months)
- Demographic characteristics of aRCC patients as measured by continuous statistics: Smoking status(Up to 36 months)
- Demographic characteristics of aRCC patients as measured by continuous statistics: Healthcare coverage (medical and drug)(Up to 36 months)
- Sequence of therapy events including treatment modalities(Up to 36 months)
- Drug use characteristics including dosing regimens : Formulations(Up to 36 months)
- Drug use characteristics including dosing regimens : Dose(Up to 36 months)
- Drug use characteristics including dosing regimens: Duration of therapy(Up to 36 months)
- Demographic characteristics of aRCC patients as measured by categorical statistics: Gender(Up to 36 months)
- Switching and/or discontinuation rate(Up to 36 months)
- Drug use characteristics including dosing regimens: Drugs included in each course of therapy(Up to 36 months)
研究者
研究点 (1)
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