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。

Pharmacogenetic Testing for Medication Management.

2019年7月30日 更新者:First Vitals LLC

Medication Interactions to Detect Adverse Situations

The Study is a single-arm prospective trial of patients receiving at least one medication with a known association between genetics and drug metabolism. All patients will undergo genetic testing as determined by their treating physician. The specific genes tested will, in general, be based upon the drugs the patients are taking or those that the patient's treating physician is considering as potential substitutes for current medications.

研究概览

详细说明

In this data collection only trial design, the PGx test is not a protocol-specified procedure. Rather, patients are eligible if they have undergone PGx testing within the last 90 days. Thus, PGx testing will not be performed solely for inclusion in this clinical research initiative.

研究类型

观察性的

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

概率样本

研究人群

The Study will include male or female patients 18 years of or older who are receiving at least one medication with metabolism known to depend on genetic variation and have the PGx test already performed. The patient must also meet the inclusion/ exclusion criteria established by the protocol.

描述

Inclusion Criteria:

  1. Patient underwent PGx testing for alleles appropriate to the target drugs within the prior 90 days ("index PGx test");
  2. Male or female patients 18 years or older who have given their written Informed Consent to participate in a Clinical Study based on voluntary agreement a through explanation of the patient's participation is provided to them. Patients must have adequate reading and writing abilities such that they can comprehend and answer the questions on the patient- completed assessments and Informed Consent Form;
  3. Patient was receiving at least one medication known to be associated with allelic variation at the time of the index PGx test), including over-the-counter medications;

5. Patient has a history of at least one TDAE over the 12-month period preceding receipt of PGx test results, or has experienced inadequate efficacy from a target drug and receiving medical coverage through a private insurance.

Exclusion Criteria:

  1. Patient is currently hospitalized;
  2. Patient's medical and medication history is unavailable over the 90-day period preceding the receipt of PGx testing;
  3. Patient is unable to provide an accurate history due to mental incapacity;
  4. Patient is known to have undergone prior PGx testing for genes specific to the target drug(s), exclusive of the PGx test relating to this Study.

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

  • 观测模型:仅案例
  • 时间观点:其他

队列和干预

团体/队列
干预/治疗
No treatment.
Data collection only trial design.
Data collection only trial design.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
The primary endpoint of the Study is the binary occurrence of meaningful change in drug regimen.
大体时间:90-day period following receipt of PGx test results
90-day period following receipt of PGx test results

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。

调查人员

  • 研究主任:Ernie Lee, CHRS、First Vitals LLC

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1月1日

初级完成 (实际的)

2018年5月1日

研究完成 (实际的)

2018年5月1日

研究注册日期

首次提交

2015年9月22日

首先提交符合 QC 标准的

2015年9月22日

首次发布 (估计)

2015年9月24日

研究记录更新

最后更新发布 (实际的)

2019年8月1日

上次提交的符合 QC 标准的更新

2019年7月30日

最后验证

2019年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • MIDAS

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