Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

  • STATUS
    Recruiting
  • End date
    Aug 11, 2022
  • participants needed
    600
  • sponsor
    Abramson Cancer Center of the University of Pennsylvania
Updated on 11 September 2021
cancer

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.

Details
Condition Gastrointestinal Neoplasm, GASTROINTESTINAL DISORDER, Neoplasm of unspecified nature of digestive system, Gastrointestinal Diseases and Disorders, Digestive System Neoplasms, gastrointestinal cancer, gastrointestinal cancers
Treatment Pharmacogenetic test
Clinical Study IdentifierNCT04736472
SponsorAbramson Cancer Center of the University of Pennsylvania
Last Modified on11 September 2021

Eligibility

Yes No Not Sure

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 sampling for PGx testing and comply with all study-related procedures
Life expectancy of at least 6 months
ECOG performance status of 0, 1 or 2

Exclusion Criteria

Prior treatment with fluoropyrimidines and/or 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
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