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Pharmacogenetic Testing
Pharmacogenetic Testing for Gastrointestinal Cancer (IMPACT-GI Trial)
N/A
Waitlist Available
Led By Sony Tuteja, PharmD, MS
Research Sponsored by Abramson Cancer Center at Penn Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pathologically confirmed gastrointestinal malignancy for which treatment with a fluoropyrimidine and/or irinotecan is indicated
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
IMPACT-GI Trial Summary
This trial is studying a pharmacogenetic test to see if it can help guide cancer treatment decisions and improve patient outcomes.
Who is the study for?
This trial is for adults over 18 with gastrointestinal cancer who need treatment with specific chemotherapy drugs and can give informed consent. They must be willing to provide a blood or saliva sample, have a life expectancy of at least 6 months, and agree to follow study procedures. People who've had prior treatments with irinotecan, know their DPYD/UGT1A1 genotype, have severe kidney/liver issues, are pregnant/breastfeeding, or whose doctor advises against it cannot join.Check my eligibility
What is being tested?
The study tests if using pharmacogenetic testing (how genes affect drug response) in clinical practice helps doctors choose better chemotherapy doses for gastrointestinal cancers. All participants will get genotyping tests that may guide treatment decisions based on their genetic makeup.See study design
What are the potential side effects?
Since this trial focuses on the implementation of genetic testing rather than the drugs themselves, direct side effects from the intervention are minimal. However, there might be general risks associated with providing a blood or saliva sample.
IMPACT-GI Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My stomach or intestine cancer needs treatment with specific chemotherapy drugs.
IMPACT-GI Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility: proportion of pharmacogenetic tests returned prior to initial dose
Fidelity: level of agreement with dose recommendations
Penetrance: proportion of pharmacogenetic tests ordered by providers
Secondary outcome measures
Grade 3 or higher toxicity
IMPACT-GI Trial Design
1Treatment groups
Experimental Treatment
Group I: DPYD/UGT1A1 pharmacogenetic testingExperimental Treatment1 Intervention
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
First Studied
Drug Approval Stage
How many patients have taken this drug
Pharmacogenetic test
2020
N/A
~150
Find a Location
Who is running the clinical trial?
Abramson Cancer Center at Penn MedicineLead Sponsor
387 Previous Clinical Trials
145,379 Total Patients Enrolled
Abramson Cancer Center of the University of PennsylvaniaLead Sponsor
359 Previous Clinical Trials
104,779 Total Patients Enrolled
Sony Tuteja, PharmD, MSPrincipal Investigator - University of Pennsylvania
University of Pennsylvania
2 Previous Clinical Trials
571 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I am 18 years old or older.I have been treated with irinotecan before.You are expected to live for at least 6 more months.I know my DPYD and UGT1A1 gene status.I am willing to give blood or saliva samples for genetic testing and follow all study rules.My doctor advises against my participation in this trial.My blood, liver, and kidney tests are within normal ranges.My stomach or intestine cancer needs treatment with specific chemotherapy drugs.
Research Study Groups:
This trial has the following groups:- Group 1: DPYD/UGT1A1 pharmacogenetic testing
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are participants still being welcomed into this experiment?
"According to clinicaltrials.gov, this medical examination is currently receiving participants. It was initially announced on March 26th 2021 and had its most recent update on September 20th 2022."
Answered by AI
How many individuals are involved in this research endeavor?
"Affirmative, the clinical trial is actively recruiting as indicated by information on clinicaltrials.gov. This experiment was made available to participants since March 26th 2021 and has been modified most recently on September 20th 2022. The researchers are looking for 600 individuals across 3 sites."
Answered by AI
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