A Study to Improve the Awareness of Mucopolysaccharidosis Type II in Brazil
2022年5月6日 更新者：Takeda
Mucopolysaccharidosis Type II in Brazil: A Retrospective Secondary Database Study (Informatics Department of Brazilian Health System - DATASUS)
The main aims of the study are to learn about the percentage of mucopolysaccharidosis type II (MPS II) in adults in Brazil as well as about the diagnosis process.
No study medicines will be provided to participants in this study.
The data available for participants diagnosed with MPS II in DATASUS (a database of the Informatics Department of Brazilian Health System) will be reviewed.
No clinic visits will be required as part of participation in this study.
研究概览
研究类型
观察性的
注册 (实际的)
250
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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São Paulo、巴西、04794-000
- Takeda Distribuidora Ltda
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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
- 孩子
- 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
Participants diagnosed with MPS II cases in Brazil.
描述
Inclusion Criteria:
All MPS II cases of (International Classification of Diseases, 10th revision [ICD-10] E76.1) at any age reported in DATASUS from January 1st, 2008 to September 30th, 2020 will be included.
Exclusion Criteria:
MPS II cases reported outside this period will be excluded.
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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Participants With MPS II
Retrospective data of participants diagnosed with MPS II will be collected from the database (DATASUS) from January 1st, 2008 to September 30th, 2020 in this observational study.
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这是一项非干预性研究。
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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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Number of Participants Diagnosed With MPS II
大体时间：From January 1, 2008 to September 30, 2020
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Number of participants diagnosed with MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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Number of Participants with Comorbidities Associated with MPS II
大体时间：From January 1, 2008 to September 30, 2020
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Comorbidities will be like respiratory infections, carpal tunnel syndrome and hernia.
Number of participants with comorbidities associated with MPSII will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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Age of MPS II Diagnosis
大体时间：From January 1, 2008 to September 30, 2020
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Age of MPS II diagnosis will be calculated from the date of birth and date of diagnosis.
Retrospective data of participants will be collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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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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Number of Health Care Professionals Who Diagnosed MPS II
大体时间：From January 1, 2008 to September 30, 2020
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Number of health care professionals who diagnosed the MPS II will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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Number of Health Care Professionals Consulted
大体时间：From January 1, 2008 to September 30, 2020
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Number of health care professionals consulted before MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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Time to MPS II Diagnoses
大体时间：From January 1, 2008 to September 30, 2020
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Time between first Unified Health System (a Brazilian Health System) consultation and MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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Time Between MPS Diagnosis II and Start of Treatment
大体时间：From January 1, 2008 to September 30, 2020
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Time between MPS diagnosis II and start of treatment will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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Number of Treatments Received Before and After MPS II Diagnosis
大体时间：From January 1, 2008 to September 30, 2020
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Number of treatments received by participant before and after MPS II diagnosis will be reported based on the retrospective data of participants collected from the database (DATASUS).
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From January 1, 2008 to September 30, 2020
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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。
赞助
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 (实际的)
2021年12月6日
初级完成 (实际的)
2022年2月15日
研究完成 (实际的)
2022年2月15日
研究注册日期
首次提交
2021年11月30日
首先提交符合 QC 标准的
2021年11月30日
首次发布 (实际的)
2021年12月13日
研究记录更新
最后更新发布 (实际的)
2022年5月9日
上次提交的符合 QC 标准的更新
2022年5月6日
最后验证
2022年5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
- TAK-765-5001
- MACS-2021-021601 (其他标识符：Takeda)
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
是的
IPD 计划说明
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5).
These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.
IPD 共享访问标准
IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/
For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
IPD 共享支持信息类型
- 研究方案
- 树液
- 国际碳纤维联合会
- 企业社会责任
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
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.