Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 6
- 主要终点
- Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose
研究概览
简要总结
Pharmacogenomics (PGx) is the study of how genes affect a person's response to drugs. PGx testing for certain genes can help predict the risk of side effects from chemotherapy agents. Testing is not regularly performed in clinical practice due to long wait times for results and challenges with integrating test results in the electronic health record. Investigators leading this study hope to find out if providing cancer care providers with the ability to order a PGx test and electronically receive results with dosing recommendations will increase the use of these tests to guide treatment decisions and improve patient outcomes.
This is a non-randomized implementation study, which means that all participants in this study will undergo genotyping for a pharmacogenetic test. The investigators will primarily measure the feasibility of using this test to guide cancer care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
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
- •Able and willing to provide informed consent
- •Male or female, aged 18 years or older at the time of study initiation
- •Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated
- •Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures
- •Life expectancy of at least 6 months
排除标准
- •Prior treatment with irinotecan
- •DPYD or UGT1A1 genotype already known
- •Severe renal or hepatic impairment (or unacceptable laboratory values), including:
- •Neutrophil count of <1.5 x 109/L, platelet count of <100 x 109/L
- •Hepatic function as defined by serum bilirubin >1.5 x upper limit of normal (ULN), alanine aminotransferase (ALT), and aspartate aminotransferase (AST) >2.5 x ULN, or in case of liver metastases ALT and AST>5 x ULN
- •Renal function as defined by serum creatinine >1.5 x ULN, or creatinine clearance <60 ml/min (by Cockcroft-Gault Equation)
- •Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study
- •Treating physician does not want subject to participate
结局指标
主要结局
Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose
时间窗: 14 days
The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
Fidelity: Level of Agreement With Dose Recommendations
时间窗: 14 days
The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.
Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers
时间窗: 14 days
The number and percentage of participants with pharmacogenetic tests ordered compared to the number of patients eligible for testing at participating sites during the study timeframe
次要结局
- Severe Treatment Related Adverse Events (TRAE)(6 months)
研究者
Sony Tuteja
Principal Investigator
University of Pennsylvania