Personalised Therapeutics @ Leiden University Medical Center
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- ADRs grade >3 total
研究概览
简要总结
In PT@LUMC 2000 patients will be randomized between a PGx-guided dosing group and a standard of care group. The patients will be followed for one year in which they will be asked to report adverse drug reactions at one, three, six and twelve months.
详细描述
Rationale: Pharmacogenomics (PGx) is the study of genetic variability affecting an individual's response to a drug. PGx is a critical component of personalized medicine. Currently, PGx is applied for individual drugs and/or individual genetic variants. Recently a pre-emptive panel-based approach was proposed including 48 PGx variants covering 13 genes for which the Dutch Pharmacogenetic Working Group (DPWG) has issued evidence based drug dosing guidelines. The PGx panel contains all genetic variants that are considered actionable by the DPWG i.e. requiring a dose adjustment or switch to another drug. Interestingly, more than 95% of the Dutch population carries one or more actionable genotype(s) for one of the genes covered by this panel and 10% carries 4 or more. Based upon national prescription data we estimate that 5.6% of all first prescriptions would require an individualization of the dose or drug. However, in current clinical practice the potential of PGx testing is not fully exploited and the impact for LUMC is unknown. Therefore a prospective study on pre-emptive PGx testing will be performed in the LUMC. In this study 2.000 patients will be randomized to PGx-guided dosing or standard of care.
In addition, we plan to conduct sub-studies with the obtained data. The first study aims to explore novel associations of genetic variants with variability in drug response. The second aims to explore the impact of concomitant medication and other non-genetic factors on pharmacogenetic associations in a pragmatic setting.
Primary objective: To implement pre-emptive panel based PGx testing in the LUMC and determine patient benefit of PGx guided drug prescription and dispensing.
Study design: A prospective, open, randomized study in 2,000 patients with a duration of 2 years.
Study population: Patients over 18 years old undergoing medication verification in the LUMC.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Provision of informed consent (IC) prior to any study specific procedures.
- •Be aged ≥18
- •A venapunction as part of routine treatment
- •Receive a medication verification interview
- •Be able and willing to be followed-up for at least one year
排除标准
- •Pregnancy or lactating
- •Previous participation in the PREPARE trial (NCT03093818, NL60069.058.16)
研究组 & 干预措施
PGx-guided dosing
This group will be genotyped for 14 pharmacogenes at the start of the study.
干预措施: Genetic test for 14 pharmacogenes (Genetic)
Standard of care
This group will be genotyped for 14 pharmacogenes at the end of the study.
结局指标
主要结局
ADRs grade >3 total
时间窗: One year
The primary outcome will be the occurrence of clinically relevant (classified as NCI-CTCAE grade 3, 4, or 5) patient reported ADRs within one year of follow-up.
次要结局
- Cost-effectiveness(One year)
- ADRs grade >3(One, three, six and twelve months)
- Frequency of PGx drug prescriptions(One year)
- Acceptance to recommendations(One year)
- ADRs grade >2 total(One year)
- ADRs grade >2(One, three, six and twelve months)
研究者
J.J.Swen
Professor of Clinical Pharmacy and Pharmacogenetics
Leiden University Medical Center