Status:
COMPLETED
Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
Lead Sponsor:
Abramson Cancer Center at Penn Medicine
Conditions:
Gastrointestinal Cancer
Eligibility:
All Genders
18+ years
Phase:
NA
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 r...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 26 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 9 2024
Estimated Enrollment :
552 Patients enrolled
Trial Details
Trial ID
NCT04736472
Start Date
March 26 2021
End Date
October 9 2024
Last Update
June 6 2025
Active Locations (3)
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1
Lancaster General Hospital
Lancaster, Pennsylvania, United States, 17604
2
Penn Presbyterian Medical Center
Philadelphia, Pennsylvania, United States, 19104
3
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104