Treatment Patterns and Outcomes Study in Patients With Unresectable Stage III and Metastatic (Stage IV) Melanoma in the United States
2018年2月5日 更新者：Bristol-Myers Squibb
This study will collect real-world data from advanced melanoma diagnosis through most recent visit and data sourced from patient medical records following a 2-part study design consisting of a random sample (Part 1) and an oversample (Part 2).
研究概览
研究类型
观察性的
注册 (实际的)
650
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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New Jersey
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Morristown、New Jersey、美国、07960
- Local Institution
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Patients initiating a new line of therapy for unresectable stage III and/or metastatic (stage IV) melanoma during the index period between 01-Jan-2015 and 31-May-2016.
描述
Inclusion Criteria:
- Adults 18 years or older
- Diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma before 01-Nov-2015
- Initiating a new line of therapy during the index period between 01-Jan-2015 and 31-May-2016, irrespective of advanced melanoma diagnosis date
- Medical history available for medical chart abstraction from date of diagnosis through most recent or current therapy (defined as end of data collection period)
Exclusion Criteria:
- Physicians unwilling or unable to follow study instructions
- Patients who were previously enrolled in a cancer treatment-related clinical trial since the diagnosis of unresectable stage III and/or metastatic (stage IV) melanoma
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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advanced melanoma patients
Part 1 will consist of a representative sample of advanced melanoma patients, irrespective of date of diagnosis of stage III unresectable and metastatic/stage IV, to address information objectives on treatment patterns, clinical outcomes, and resource use after the start of treatment post-launch of new drugs, ie, since 2011 for ipi and 2015 for ipi + nivo in advanced melanoma
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非介入式
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Ipi monotherapy
Part 2: patients must have been prescribed Ipi monotherapy during the index period between 01-Jan-2015 and 31-May-2016.
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非介入式
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Ipi + nivo combination therapy
Part 2: patients must have been prescribed Ipi + nivo combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
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非介入式
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Dabrafenib + trametinib combination therapy
Part 2: patients must have been prescribed Dabrafenib + trametinib combination therapy during the index period between 01-Jan-2015 and 31-May-2016.
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非介入式
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Pembro monotherapy
Part 2: patients must have been prescribed Pembro monotherapy during the index period between 01-Jan-2015 and 31-May-2016
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非介入式
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Nivo monotherapy
Part 2: patients must have been prescribed Nivo monotherapy during the index period between 01-Jan-2015 and 31-May-2016
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非介入式
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
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Distribution of treatment patterns for advanced melanoma patients
大体时间：Aproximately 6 months
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Distribution of treatment patterns for advanced melanoma patients including, treatment regimen selection and rationale, as well as time to initiation of therapy and type of therapy
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Aproximately 6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Distribution of prescribing patterns
大体时间：Approximately 16 months
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Distribution of prescribing patterns by type of practice setting and melanoma patient volume
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Approximately 16 months
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Distribution of Patient Age at index date
大体时间：at baseline
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Patient Age at index date will be determined from Medical Records
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at baseline
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Distribution of Patient's Sex at Index Date
大体时间：At Baseline
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Patient's sex will be determined from Medical Records
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At Baseline
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Distribution of Comorbidities at index date
大体时间：At Baseline
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Comorbidities will be determined using the Charlson Comorbidity Index (CCI)
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At Baseline
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Distribution of Healthcare Coverage type
大体时间：At Baseline
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Healthcare Coverage type will be determined using Medical Records
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At Baseline
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Distribution of Diagnosis Date
大体时间：At Baseline
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Melanoma Diagnosis Date will be determined using medical records
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At Baseline
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Distribution of Advanced Diagnosis Date
大体时间：At Baseline
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Date of advanced/ metastatic melanoma diagnosis will be determined using medical records
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At Baseline
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Distribution of Age at Onset
大体时间：At Baseline
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Diagnosis date-Date of Birth
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At Baseline
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Distribution of Disease stage at time of diagnosis
大体时间：At Baseline
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Disease stage at time of diagnosis will be determined using medical records
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At Baseline
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Distribution of Disease stage at subsequent visits
大体时间：Approximately 16 months
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Disease stage at subsequent visits will be determined using medical records
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Approximately 16 months
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Distribution of ECOG status at Baseline
大体时间：At Baseline
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Eastern Cooperative Oncology Group (ECOG) status at Baseline will be determined using medical records
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At Baseline
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Distribution of ECOG status at Last Visit
大体时间：Approximately 16 months
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Eastern Cooperative Oncology Group (ECOG) status at Last Visit will be determined using medical records
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Approximately 16 months
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Distribution of Biomarker status at baseline
大体时间：at baseline
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Biomarker status will be determined using Medical Records
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at baseline
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Distribution of treatment-related adverse events
大体时间：Approximately 16 months
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treatment-related adverse events will be determined using medical records
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Approximately 16 months
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Distribution of Overall Survival (OS) from Advanced Diagnosis
大体时间：Approximately 16 months
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Date of death minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of Progression-Free Survival (PFS) at Advanced Diagnosis
大体时间：Approximately 16 months
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Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus advanced/metastatic diagnosis date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of Overall Response Rate (ORR)
大体时间：Approximately 16 months
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Approximately 16 months
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Distribution of Overall Survival (OS) from Index Date
大体时间：Approximately 16 months
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Date of death minus index treatment start date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of Progression-Free Survival (PFS) at Index Date
大体时间：Approximately 16 months
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Date of progression (increase in tumor size or increase in cancer stage)/start of next line of therapy minus index treatment start date, censoring for LTF or end of observation
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Approximately 16 months
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Distribution of melanoma related HCRU
大体时间：Approximately 16 months
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Approximately 16 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2016年10月25日
初级完成 (实际的)
2017年10月30日
研究完成 (实际的)
2017年12月31日
研究注册日期
首次提交
2017年6月23日
首先提交符合 QC 标准的
2017年6月23日
首次发布 (实际的)
2017年6月27日
研究记录更新
最后更新发布 (实际的)
2018年2月6日
上次提交的符合 QC 标准的更新
2018年2月5日
最后验证
2018年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
非介入式的临床试验
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Sheffield Hallam UniversitySheffield Teaching Hospitals NHS Foundation Trust完全的
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Charite University, Berlin, Germany招聘中