Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI)

Abramson Cancer Center at Penn Medicine

Status: Completed

Conditions: Gastrointestinal Cancer

Treatments: Device: Pharmacogenetic test

Study type: Interventional

Funder types: Other

Identifiers

NCT04736472

844763

UPCC 22220

Details and patient eligibility

About

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.

Enrollment: 552 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Able and willing to provide informed consent
2. Male or female, aged 18 years or older at the time of study initiation
3. Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated
4. Willing to undergo blood or saliva sampling for PGx testing and comply with all study-related procedures
5. Life expectancy of at least 6 months

Exclusion criteria

1. Prior treatment with irinotecan

2. DPYD or UGT1A1 genotype already known

3. 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)

4. Women who are pregnant or breast feeding, or subjects who refuse to use reliable contraceptive methods throughout the study

5. Treating physician does not want subject to participate

Trial design

Primary purpose: Other

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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552 participants in 1 patient group

DPYD/UGT1A1 pharmacogenetic testing

Experimental group

Description:

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.

Treatment:

Device: Pharmacogenetic test