Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases in a Medicare Population
2018年9月17日 更新者：Bayer
Treatment Patterns in Castrate Resistant Prostate Cancer Patients With Bone Metastases
The goal of the study is to provide a detailed description of treatments for CRPC (Castrate Resistant Prostate Cancer) patients with bone metastases and the resource utilization and costs associated with that diagnosis and subsequent treatments.
研究概览
研究类型
观察性的
注册 (实际的)
1163
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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Kentucky
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Louisville、Kentucky、美国
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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
55年 至 88年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
男性
取样方法
非概率样本
研究人群
Castrated resistant prostate cancer patients with bone metastases
描述
Inclusion Criteria:
- First diagnosis for bone metastases for members diagnosed with prostate cancer found in the claims data during the identification period
- Members age ≥ 55 to 89 years at index
- Medicare members with medical and pharmacy coverage; and
- Continuously enrolled during the pre- and post-index periods.
Exclusion Criteria:
- Member with diagnosis of any other cancer (excluding melanoma (ICD-9 172.x) and other metastases (ICD-9 198.x)) before the index date; and
- Members age ≥ 89 years of age at index date
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 |
|---|---|
|
Cohort 1 / Treatment patterns
Patients with castrated resistant prostate cancer and bone metastases
|
Therapies used to treat prostate cancer and more specifically castrate resistant prostate cancer inclusively Xofigo (Radium-223 dichloride, BAY88-8223)
|
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 |
|---|---|---|
|
Overall survival of mCRPC patients
大体时间：Up to 24 months
|
mCRPC: Metastatic castrate-resistant prostate cancer
|
Up to 24 months
|
|
Number of skeletal related events (SREs) of the mCRPC patients
大体时间：Up to 30 months
|
Up to 30 months
|
|
|
Type of skeletal related events (SREs) of the mCRPC patients
大体时间：Up to 30 months
|
Up to 30 months
|
|
|
Number of patients with mCRPC with bone metastases
大体时间：Up to 24 months
|
Up to 24 months
|
|
|
Type of treatments associated with mCRPC
大体时间：Up to 24 months
|
Treatments could include chemotherapy or bone radiation
|
Up to 24 months
|
|
Duration for each treatment identified
大体时间：Up to 30 months
|
Up to 30 months
|
|
|
Distribution of providers by treatment
大体时间：Up to 30 months
|
Distribution of treatments for mCRPC patients will be tracked by the type of provider (oncologist, versus urologist, versus radiation oncologist, etc)
|
Up to 30 months
|
|
Clinical and demographic characteristics of the mCRPC patients
大体时间：Up to 12 months
|
Gender, age, geographical region and race/ethnicity, Key comorbidities will also be documented using the Deyo-Charlson Comorbidity Index (DCCI); laboratory results for Prostate-Specific Antigen (PSA) and alkaline phosphatase (ALP) testing using laboratory claims; Rx utilization including opioid use
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Up to 12 months
|
|
Treatment patterns of mCRPC patients with bone metastases
大体时间：Up to 30 months
|
Up to 30 months
|
|
|
Progression of the disease of mCRPC patients
大体时间：Up to 12 months
|
Up to 12 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
All-cause healthcare resource utilization for mCRPC patients
大体时间：Up to 30 months
|
Using all post-index medical and pharmacy claims, compute the count of physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services, and count of pharmacy claims
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Up to 30 months
|
|
mCRPC-specific healthcare resource utilization for mCRPC patients
大体时间：Up to 30 months
|
Healthcare resource utilization will be measured using all post-index medical and pharmacy claims to create counts for physician office visits, outpatient services, inpatient stay, length of inpatient stay, ancillary services and counts of pharmacy claims
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Up to 30 months
|
|
All-cause healthcare costs for mCRPC patients
大体时间：Up to 30 months
|
Healthcare costs will be determined using all post-index medical and pharmacy claims.
The all-cause total (medical + pharmacy), medical and pharmacy costs will be computed.
A family of general linear model analysis will be performed (medical, pharmacy, and total costs)
|
Up to 30 months
|
|
mCRPC-specific healthcare costs for mCRPC patients
大体时间：Up to 30 months
|
Healthcare costs will be determined using all post-index medical and pharmacy claims where a diagnosis of mCRPC appears in any of the nine diagnosis positions.
The mCRPC specific total (Medical + pharmacy), medical and pharmacy costs associated with these claims will be computed.
|
Up to 30 months
|
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。
赞助
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)
2015年8月31日
初级完成 (实际的)
2017年9月30日
研究完成 (实际的)
2017年9月30日
研究注册日期
首次提交
2015年8月6日
首先提交符合 QC 标准的
2015年8月6日
首次发布 (估计)
2015年8月10日
研究记录更新
最后更新发布 (实际的)
2018年9月18日
上次提交的符合 QC 标准的更新
2018年9月17日
最后验证
2018年9月1日
更多信息
与本研究相关的术语
其他研究编号
- 18273
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.