N/A
N=531
Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
Gastrointestinal Cancer
Bottom Line
View on ClinicalTrials.gov: NCT04736472 ↗Enrolled (actual)
531
Serious AEs
32.7%
Results posted
Jun 2025
Primary outcome: Primary: Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose — 130; 95 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Pharmacogenetic test (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Abramson Cancer Center at Penn Medicine
- Primary completion
- Dec 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose |
130; 95 | — |
| PRIMARY Fidelity: Level of Agreement With Dose Recommendations |
11; 6; 5 | — |
| PRIMARY Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers |
288 | — |
| SECONDARY Severe Treatment Related Adverse Events (TRAE) |
6; 63; 10; 66; 10; 6 | .224 |
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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 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
Data sourced from ClinicalTrials.gov (NCT04736472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.