此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

Dosing and Outcomes Study of Erythropoietic Stimulating Therapies in Patients With Chemotherapy Induced Anemia (DOSE)

2014年6月27日 更新者:Ortho Biotech Products, L.P.

Dosing and Outcomes Study of Erythropoietic Stimulating Therapies

The purpose of this study is to describe patient characteristics, treatment patterns, and clinical outcomes in adult patients with cancer who are receiving erythropoiesis-stimulating therapy (EST).

研究概览

详细说明

The Dosing and Outcomes Study of Erythropoietic Stimulating Therapies (DOSE) is a prospective, observational multicenter registry of approximately 1200 adult cancer patients receiving treatment with EST; eg, epoetin alfa or darbepoetin alfa. The planned duration of the DOSE Registry is three years. Based on initial results, the registry sponsor may elect to extend the duration of the registry.This study does not specify treatment protocols, require any particular assignment of patients to treatment protocols, or in any other way require participating physicians to alter their practice patterns. Participating physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on baseline patient characteristics, treatment patterns, and clinical outcomes. Baseline determinations will include patient demographics, tumor and treatment type, hematologic parameters, and patient reported outcomes. Data will be collected over the 16-week study period with regard to EST treatment, hematologic outcomes and patient reported outcomes.

研究类型

观察性的

注册 (实际的)

2130

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 who are being treated with an erythropoiesis-stimulating therapy for chemotherapy induced anemia.

描述

Inclusion Criteria:

  • Patients with cancer who are being treated with an erythropoiesis-stimulating therapy (EST) for anemia of cancer or cancer-related treatment
  • Must be EST ''naive'' globally or must have been off treatment with an EST for at least 90 days
  • Must speak and read english and be able to answer the type of simple questions presented in the patient questionnaires
  • If the patient is identified for the study while an inpatient, they must be able to be followed for up to 16 weeks
  • The patient must give consent to participate in the registry by signing the informed consent form

Exclusion Criteria:

  • Patients currently participating in any other clinical study of EST (however, the patient may be undergoing treatment under an investigational cancer treatment protocol)
  • Have or had been on dialysis for end stage renal disease in the past
  • Has myelodysplasia or any myelodysplastic syndrome
  • Patients are known to need stem cell transplant
  • Patient who will self-administer the epoetin alfa or darbepoetin alfa

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
Patients with chemotherapy induced anemia
Physicians are instructed to continue to treat all patients according to their own best clinical judgment, but to submit information on the parameters and outcomes of this treatment to the database. Patients will have to fill the questionaire at the time of enrollment and baseline.

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
To document patient characteristics and patterns of clinical management
大体时间:Up to 3 years
The clinical management includes changes in chemotherapy, radiation, bleeding, missed EST doses.
Up to 3 years

次要结果测量

结果测量
大体时间
To assess the relationships between patient characteristics, treatment patterns and outcomes
大体时间:Up to 3 years
Up to 3 years
To measure economic impacts, and quality of life
大体时间:Up to 3 years
Up to 3 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。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

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

2003年12月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2009年7月1日

研究注册日期

首次提交

2005年9月13日

首先提交符合 QC 标准的

2005年9月13日

首次发布 (估计)

2005年9月21日

研究记录更新

最后更新发布 (估计)

2014年6月30日

上次提交的符合 QC 标准的更新

2014年6月27日

最后验证

2014年6月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • CR004561
  • ABT-OP-03-02 (其他标识符:Ortho Biotech Products, L.P.)

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.

订阅