NCT00928031已完成不适用
Collection of Long-Term Outcome Data for Subjects Who Have Previously Participated in Selected Ipilimumab (MDX-010) Studies in Metastatic Melanoma
Bristol-Myers Squibb11 个研究点 分布在 1 个国家目标入组 160 人开始时间: 2007年6月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 160
- 试验地点
- 11
研究概览
简要总结
The objective of this study is to collect disease status and overall survival information for all Subjects in MDX-010 studies.
详细描述
This is a multicenter, follow-up study in up to 191 subjects with metastatic melanoma who were previously enrolled and treated in ipilimumab studies MDX010-02, MDX010-08, and MDX010-15. The purpose of this study is to 1) collect the date and cause of death, if known, for all deceased subjects who participated in any of the specified studies; 2) collect the date of progression for subjects who completed the studies with stable disease or better; and 3) prospectively follow all surviving subjects to determine progression-free and overall survival.
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
- •Subjects who were previously enrolled in MDX-010 studies MDX010-02, MDX010-08, or MDX010-
- •Subjects (or if applicable, next of kin), who are alive at the time of contact must have read, understood, and provided written informed consent and health Insurance Portability and Accountability Act (HIPAA) authorization after the nature of the study has been fully explained.
- •For subjects who have died or have been lost to follow-up(the subject status at end of original ipilimumab study), approval from the appropriate site IRB, specifying or limiting appropriate means for obtaining information, must be granted prior to collection of any information.
排除标准
- 未提供
研究者
研究点 (11)
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