Gastrointestinal CancerIMPACT-GINCT04736472

Implementing Pharmacogenetic Testing in Gastrointestinal Cancers

A study testing Pharmacogenetic test in people with Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Gastrointestinal Cancer
What is being tested?: Pharmacogenetic test
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 552 participants
Where: 3 sitesUnited States
Study dates: 26 Mar 2021to 9 Oct 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

3 sites in 1 country.

United States3 sites

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

Other trials in United States

About this study

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.

Conditions: Gastrointestinal Cancer
Being tested: Pharmacogenetic test
Keywords: Gastrointestinal Neoplasms, Fluorouracil, Capecitabine, Irinotecan, Fluoropyrimidines, Topoisomerase I inhibitors, Antimetabolites, Antineoplastics, Molecular Mechanisms of Pharmacological Action
Medical subject headings: Gastrointestinal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Pharmacogenetic testDevice
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.

Study groups in NCT04736472
Study group	Role	What they receive
DPYD/UGT1A1 pharmacogenetic testing	Experimental	All patients will be screened for twelve single nucleotide polymorphisms (SNPs) in DPYD: DPYD2A, 5, 6, 8, 9A, 10, 12, 13, rs2297595, rs115232898, rs67376798, HapB3. All patients will be screened for two SNPs in UGT1A1: UGT1A16, 28. Receives: Device: Pharmacogenetic test

What is being measured

The primary outcome is the main question the study is designed to answer.

Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose
The Number and percentage of participants who had their pharmacogenetic tests returned prior to the first determined dose of chemotherapy.
Measured: 14 days
Fidelity: Level of Agreement With Dose Recommendations
The number and percentage of participants with dose modifications made in agreement with the genotype-guided dosing recommendations for the first dose of chemotherapy.
Measured: 14 days
Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers
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
Measured: 14 days

Secondary outcomes (1)

Severe Treatment Related Adverse Events (TRAE)
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.
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

26 Mar 20219 Oct 2024

First posted3 Feb 2021
Study start26 Mar 2021
Primary completion19 Dec 2023
Study completion9 Oct 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Gastrointestinal CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Model description: This is a nonrandomized, open-label study to investigate the feasibility of establishing and integrating a pharmacogenetic test into clinical oncology care. A historical control group of patients with gastrointestinal cancers enrolled in a biobank will be used to compare toxicity outcomes of the prospectively-genotyped patients.
Masking: None (open label)
Enrolment: 552 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04736472
Sponsor's protocol ID: UPCC 22220
Other IDs: 844763
Acronym: IMPACT-GI
Status last verified: Jun 2025
First submitted: 29 Jan 2021
Last updated: 6 Jun 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Data will be made available upon reasonable request.

Publications

Varughese LA, Bhupathiraju M, Hoffecker G, Terek S, Harr M, Hakonarson H, Cambareri C, Marini J, Landgraf J, Chen J, Kanter G, Lau-Min KS, Massa RC, Damjanov N, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing DPYD and UGT1A1 Screening to Guide Chemotherapy Dosing. Front Oncol. 2022 Jul 5;12:859846. doi: 10.3389/fonc.2022.859846. eCollection 2022.
PubMed 35865463

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
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RecruitingPhase 2
Toripalimab Plus Cetuximab and Irinotecan for Second-Line Right-Sided RAS/BRAF Wild-Type Advanced Colon Cancer Phase II Study
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All Gastrointestinal Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Implementing Pharmacogenetic Testing in Gastrointestinal Cancers
ClinicalTrials.gov ID: NCT04736472
Acronym / sponsor ID: IMPACT-GI / UPCC 22220
Conditions: Gastrointestinal Cancer
Keywords: Gastrointestinal Neoplasms, Fluorouracil, Capecitabine, Irinotecan, Fluoropyrimidines, Topoisomerase I inhibitors, Antimetabolites, Antineoplastics, Molecular Mechanisms of Pharmacological Action
Study type: Interventional
Recruitment status: Completed
Enrolment: 552 participants (actual)
Lead sponsor: Abramson Cancer Center at Penn MedicineUniversity, hospital or other
Study start: 26 Mar 2021 (actual)
Primary completion: 19 Dec 2023 (actual)
Study completion: 9 Oct 2024 (actual)
First posted: 3 Feb 2021 (actual)
Results: Posted 6 Jun 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: This is a nonrandomized, open-label study to investigate the feasibility of establishing and integrating a pharmacogenetic test into clinical oncology care. A historical control group of patients with gastrointestinal cancers enrolled in a biobank will be used to compare toxicity outcomes of the prospectively-genotyped patients.

Arm	Type	Receives
DPYD/UGT1A1 pharmacogenetic testing	Experimental	Device: Pharmacogenetic testAll patients will be screened for twelve single nucleotide polymorphisms (SNPs) in DPYD: DPYD2A, 5, 6, 8, 9A, 10, 12, 13, rs2297595, rs115232898, rs67376798, HapB3. All patients will be screened for two SNPs in UGT1A1: UGT1A16, 28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (8 listed)

Prior treatment with irinotecan
DPYD or UGT1A1 genotype already known
Severe renal or hepatic impairment (or unacceptable laboratory values), including:
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Pharmacogenetic testPatients 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.	Device	DPYD/UGT1A1 pharmacogenetic testing

Primary outcome

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.
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.
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

1 secondary outcome

Severe Treatment Related Adverse Events (TRAE)
Time frame: 6 months

Results and safety

Results posted to the registry on 6 Jun 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Prospective Cohort	276	225
Confirmatory Cohort	20	20
BioBank Control	235	229

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

Time frame: 14 days. Count of participants. Unit: Participants

Measure	Prospective Cohort n = 225
PGx Result Returned before Chemotherapy	130
PGx Result Returned After Chemotherapy	95

Population analysed: Number and percentage of participants with both PGx test results and who began a qualifying chemotherapy. The BioBank Cohort and Confirmatory Cohort are not included in this measure as their PGx testing was intentionally ordered after their first dose of chemotherapy, therefore how many results were returned prior to first dose was not applicable.

Primary outcome: Fidelity: Level of Agreement With Dose Recommendations

Time frame: 14 days. Count of participants. Unit: Participants

Measure	Prospective Cohort n = 16
Number and percent of participants with PGx test results returned before chemotherapy initiation	11
Number and percent of participants with DPYD dose mods in agreement to genotype-recommendations	6
Number and percent of participants with UGT1A1 dose mods in agreement to genotype-recommendations	5

Population analysed: Number and percentage of participants with an actionable genetic variant also receiving an interacting chemotherapy (DPYD Poor and Intermediate Metabolizers receiving fluoropyrimidine and UGT1A1 Poor Metabolizers receiving irinotecan). The BioBank Cohort and Confirmatory Cohort are not included in this measure as their PGx testing was intentionally ordered after their first dose of chemotherapy, therefore modifying their chemotherapy to match PGx results was not applicable.

Primary outcome: Penetrance: Proportion of Pharmacogenetic Tests Ordered by Providers

Time frame: 14 days. Count of participants. Unit: Participants

Measure	Unique Patients Prescribed 5-FU n = 1566
Value	288

Population analysed: In order to calculate the penetrance of the intervention, as this was an implementation trial, it is necessary to consider the total number of patients who would have been eligible for recruitment. This includes both the prospective arms, as well as individuals in participating clinics during the study timeframe who were not approached for consent due to personnel and screening limitations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse event data was collected during the first six cycles of chemotherapy, <6 months.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Prospective Cohort	69 of 225 (30.7%)	214 of 225 (95.1%)	35 of 225
Confirmatory Cohort	10 of 20 (50%)	20 of 20 (100%)	3 of 20
BioBank Cohort	76 of 229 (33.2%)	140 of 229 (61.1%)	47 of 229

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 35865463Varughese LA, Bhupathiraju M, Hoffecker G, Terek S, Harr M, Hakonarson H, Cambareri C, Marini J, Landgraf J, Chen J, Kanter G, Lau-Min KS, Massa RC, Damjanov N, Reddy NJ, Oyer RA, Teitelbaum UR, Tuteja S. Implementing Pharmacogenetic Testing in Gastrointestinal Cancers (IMPACT-GI): Study Protocol for a Pragmatic Implementation Trial for Establishing DPYD and UGT1A1 Screening to Guide Chemotherapy Dosing. Front Oncol. 2022 Jul 5;12:859846. doi: 10.3389/fonc.2022.859846. eCollection 2022.
Individual participant dataSharing planned: Yes. Data will be made available upon reasonable request.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sony Tuteja, PharmD, MS principal investigator

University of Pennsylvania

3 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Pharmacogenetic test in people with Gastrointestinal Cancer, run by Abramson Cancer Center at Penn Medicine at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 6 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Feasibility: Number and Percentage of Participants Who Had Their Pharmacogenetic Tests Returned Prior to Initial Dose (time frame: 14 days). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04736472, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2025.