NCT05426239已完成不适用
Treatment Patterns and Outcomes in Patients With Advanced Melanoma: A Retrospective Study Using Data From the German ADOREG Registry
Bristol-Myers Squibb1 个研究点 分布在 1 个国家目标入组 1,008 人开始时间: 2019年1月9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
- 1,008
- 试验地点
- 1
- 主要终点
- Overall Survival (OS)
研究概览
简要总结
This study is a non-interventional retrospective observational study performed on secondary data from a German multi-site cohort registry, the German national registry of skin cancer (ADOReg).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Signed informed consent for inclusion in ADOReg registry must be documented at study site
- •Diagnosis of advanced (nonresectable or metastatic) melanoma in stage III or stage IV
- •Participants received any systemic therapy to treat the advanced melanoma
- •First-line systemic treatment was initiated within the index window (19-Jun-2015 to 30-Jun-2018)
排除标准
- •Age <18 years at index date
- •Receipt of clinical trial study drug at any time
结局指标
主要结局
Overall Survival (OS)
时间窗: Up to a maximum of 4 years of follow-up
次要结局
- Progression-Free Survival (PFS)(Up to a maximum of 4 years of follow-up)
- Treatment-free Survival (TFS)(Up to a maximum of 4 years of follow-up)
- Frequency of ADRs(Up to a maximum of 4 years of follow-up)
- Duration of Response (DOR)(Up to a maximum of 4 years of follow-up)
- Time to Treatment Discontinuation(Up to a maximum of 4 years of follow-up)
- Objective Response Rate (ORR)(Up to a maximum of 4 years of follow-up)
- Resolution Rate (RR) of ADRs(Up to a maximum of 4 years of follow-up)
- Treatment-free Interval (TFI)(Up to a maximum of 4 years of follow-up)
- Incidence Rate (IR) of Adverse Drug Responses (ADRs)(Up to a maximum of 4 years of follow-up)
研究者
研究点 (1)
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