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NCT Number: NCT04736472

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

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.

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Key information

Conditions

Gastrointestinal Cancer Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Lancaster General Hospital, Lancaster, Pennsylvania, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 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

Treatment and study plan

Pharmacogenetic test

Device

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.

Primary outcomes

  1. Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose

    Time frame: 14 days

    The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.

  2. Fidelity: Level of Agreement With Dose Recommendations

    Time frame: 14 days

    The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.

  3. Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers

    Time frame: 14 days

    The number and percentage of participants with pharmacogenetic tests ordered compared to the number of patients eligible for testing at participating sites during the study timeframe

Secondary outcomes

  1. Severe Treatment Related Adverse Events (TRAE)

    Time frame: 6 months

    Percentage of patients experiencing a severe TRAE (an event requiring hospitalization, emergency room visits, or oncology evaluation center). Severe TRAEs were one of the outcomes measured by the study.

Sponsors and collaborators

Lead sponsor

Abramson Cancer Center at Penn Medicine

Other

Registry information

Acronym: IMPACT-GI

Important dates

Study start
2021
Primary completion
2023
Study completion
2024
First posted
Feb 3, 2021
Registry last updated
Jun 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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