Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
- Conditions
- Gastrointestinal Cancer
- Interventions
- Device: Pharmacogenetic test
- Registration Number
- NCT04736472
- Lead Sponsor
- Abramson Cancer Center at Penn Medicine
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 316
- 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
-
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description DPYD/UGT1A1 pharmacogenetic testing Pharmacogenetic test All patients will be screened for twelve single nucleotide polymorphisms (SNPs) in DPYD: DPYD\*2A, \*5, \*6, \*8, \*9A, \*10, \*12, \*13, rs2297595, rs115232898, rs67376798, HapB3. All patients will be screened for two SNPs in UGT1A1: UGT1A1\*6, \*28.
- Primary Outcome Measures
Name Time Method Penetrance: proportion of pharmacogenetic tests ordered by providers 14 days The proportion of pharmacogenetic tests ordered compared to the number of patient with eligible for testing
Feasibility: proportion of pharmacogenetic tests returned prior to initial dose 14 days The proportion of pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
Fidelity: level of agreement with dose recommendations 14 days The proportion of dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.
- Secondary Outcome Measures
Name Time Method Severe treatment related adverse events (TRAE) 6 months Proportion of patients experiencing severe TRAE defined as requiring hospitalization, emergency room visits, or oncology evaluation center
Trial Locations
- Locations (3)
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
Lancaster General Hospital
🇺🇸Lancaster, Pennsylvania, United States
Penn Presbyterian Medical Center
🇺🇸Philadelphia, Pennsylvania, United States