Incidence, Prevalence, and Symptom Burden Associated With Advanced Renal Cell Carcinoma in Commercially Insured Population (Pharmetrics)
2013年5月9日 更新者：GlaxoSmithKline
Information on the prevalence of advanced/metastatic renal cell carcinoma and its symptom burden is limited in commercially insured adult patients.
Additionally, limited information exists on economic burden of adverse events associated with treatments for advanced/metastatic renal cell carcinoma.
An objective of the current study is to estimate the incidence, prevalence, and symptom burden associated with advanced/metastatic RCC in a US "real-world" setting.
Another objective is to quantify the economic burden of severe adverse events with agents used in management of first line advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
This study will employ a retrospective cohort design.
Analyses of health insurance claims data from a large commercially insured population will be employed in the current study.
Study subjects will consist of all persons, aged ≥18 years, with evidence of advanced RCC between January 1, 2000 and December 31, 2009; these persons will be identified based in part on case-ascertainment algorithms.
Analyses will be directed at estimating annual rates of incidence and prevalence of advanced/metastatic RCC, as well as symptom burden and costs of common severe adverse events associated with treatments used in management of advanced/metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
研究概览
地位
完全的
条件
研究类型
观察性的
注册 (实际的)
1
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 至 64年 (成人)
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
Study subjects will be selected from a source population consisting of all persons in the PharMetrics database with one or more days of eligibility for comprehensive health benefits between January 1, 2000 and December 31, 2009.
描述
Inclusion Criteria:
- two or more medical encounters with a diagnosis of kidney cancer (ICD-9-CM 189.0) or malignant neoplasm of the renal pelvis (189.1), and
- two or more medical encounters with a diagnosis of distant secondary malignant neoplasm (ICD-9-CM 197.XX-199.0, excluding 198.0 [kidney metastasis]) on different days <120 days apart (the date of the earliest such encounter will be designated the "index date").
Exclusion Criteria:
- evidence of receipt of chemotherapeutic agents indicated or used in the treatment of advanced TCC, or
- evidence of cystoscopy, biopsy of the bladder, or radical cystectomy
- evidence of any other primary cancer
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 |
|---|---|
|
Severe adverse event claims in subjects with metastatic RCC
Presence or absence of common severe treatment related adverse events (based on existence of claims) in patients with metastatic RCC.
Common severe adverse event defined as Grade 3 or higher with >=5% frequency of occurence as reported in product label.
|
Metastatic RCC patients on either sunitinib or sorafenib or bevacizumab or pazopanib (identified based on claims) will be evaluated for presence or absence of common severe adverse events.
These common severe adverse events will be identified from agent's product labels.
其他名称：
|
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 |
|---|---|---|
|
New and existing claims of metastatic renal cell carcinoma across multiple years
大体时间：2000 - 2009 (up to 10 years)
|
Identifying new and existing claims (based on claims based case-ascertainment algorithm) of metastatic renal cell carcinoma across multiple years
|
2000 - 2009 (up to 10 years)
|
|
Cost associated with management of common severe adverse events related to 1st line treatments used in metastatic renal cell carcinoma
大体时间：2000 - 2009 (up to 10 years)
|
Quantifying economic burden associated with management of common severe adverse events (defined as grade 3 and above adverse events occurring >= 5% as per product label) related to agents used in 1st line metastatic RCC (sunitinib, sorafenib, bevacizumab, and pazopanib).
Adverse events will be identified based on product labels.
|
2000 - 2009 (up to 10 years)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Quantify symptom burden associated with metastatic renal cell carcinoma
大体时间：2000 - 2009 (up to 10 years)
|
Quantifying symptom burden based on identification of claims associated with the respective symptoms.
Disease related symptoms will be identified based on published literature.
|
2000 - 2009 (up to 10 years)
|
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
2011年3月1日
初级完成 (实际的)
2011年10月1日
研究完成 (实际的)
2011年10月1日
研究注册日期
首次提交
2011年6月23日
首先提交符合 QC 标准的
2011年6月23日
首次发布 (估计)
2011年6月27日
研究记录更新
最后更新发布 (估计)
2013年5月13日
上次提交的符合 QC 标准的更新
2013年5月9日
最后验证
2013年5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.