Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI)

June 4, 2025 updated by: Sony Tuteja, Abramson Cancer Center at Penn Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

552

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Pennsylvania
      • Lancaster, Pennsylvania, United States, 17604
        • Lancaster General Hospital
      • Philadelphia, Pennsylvania, United States, 19104
        • University of Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104
        • Penn Presbyterian Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: DPYD/UGT1A1 pharmacogenetic testing

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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
14 days
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.
14 days
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
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Abramson Cancer Center at Penn Medicine

Investigators

  • Principal Investigator: Sony Tuteja, PharmD, MS, University of Pennsylvania

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2021

Primary Completion (Actual)

December 19, 2023

Study Completion (Actual)

October 9, 2024

Study Registration Dates

First Submitted

January 29, 2021

First Submitted That Met QC Criteria

January 29, 2021

First Posted (Actual)

February 3, 2021

Study Record Updates

Last Update Posted (Actual)

June 6, 2025

Last Update Submitted That Met QC Criteria

June 4, 2025

Last Verified

June 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UPCC 22220
  • 844763 (Other Identifier: University of Pennsylvania Perelman School of Medicine)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Data will be made available upon reasonable request.

IPD Sharing Time Frame

Study protocol, SAP, ICF will be made available 1 year following enrollment of the last participant. IPD will be made available 6 months after publication of study results.

IPD Sharing Access Criteria

Contact PI, Sony Tuteja, PharmD, sonyt@pennmedicine.upenn.edu with individual requests.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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