NCT04736472

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 552 (actual)
• Sponsor: Abramson Cancer Center at Penn Medicine · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Gastrointestinal Cancer

Interventions

Type	Name	Description
DEVICE	Pharmacogenetic test	Patients with reduced function alleles (DPYD intermediate or poor metabolizer and/or UGT1A1 poor metabolizer) will be recommended to receive dose reductions per clinical pharmacogenetic guidelines. Patients that do not carry actionable alleles (DPYD normal metabolizer and/or UGT1A1 normal or intermediate metabolizer) will receive standard dosing.

Timeline

• Start date: 2021-03-26
• Primary completion: 2023-12-19
• Completion: 2024-10-09
• First posted: 2021-02-03
• Last updated: 2025-06-06
• Results posted: 2025-06-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated device study