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Genetic Testing

Pharmacogenomic Testing for Cancer Care

N/A
Recruiting
Led By Peter O'Donnell, MD
Research Sponsored by University of Chicago
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Individuals of all genders, races and ethnic groups are eligible for this trial. There is no bias towards race, sex, or gender in the clinical trial outlined.
Adult patients receiving oncology care at The University of Chicago Medical Center, and for whom treatment with a fluoropyrimidine and/or irinotecan is planned
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 5 years
Awards & highlights

Study Summary

This trial will test whether providing genetic information to cancer care providers helps them to make better decisions about chemotherapy dosing and reduces side effects.

Who is the study for?
This trial is for adults at The University of Chicago Medical Center who need treatment with specific chemotherapy drugs (fluoropyrimidine and/or irinotecan) for various cancers. It's open to all genders, races, and ethnic groups. People can't join if they're in another study affecting drug doses, have had certain organ transplants or dysfunctions, don't understand the consent process, have blood cancer or chronic kidney disease, or have used these chemo drugs before.Check my eligibility
What is being tested?
The study tests whether giving doctors genetic information about patients helps tailor chemotherapy doses to reduce side effects. Participants are randomly placed into two groups: one receives pharmacogenomic guidance for dosing; the other does not (control group).See study design
What are the potential side effects?
While this trial focuses on reducing side effects by personalizing chemo doses using genetic info, common side effects of fluoropyrimidine and irinotecan may include nausea, vomiting, diarrhea, low blood counts leading to increased infection risk.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I belong to any gender, race, or ethnic group.
Select...
I am an adult patient at The University of Chicago Medical Center and will be treated with fluoropyrimidine and/or irinotecan.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 5 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Dose Deviation Rate (Co-Primary Endpoint)
Grade 3 or Higher Toxicity (Co-Primary Endpoint)
Secondary outcome measures
Cumulative Chemotherapy Dose Intensity
Overall Survival
Progression free survival (PFS)
+1 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Pharmacogenomics GroupExperimental Treatment1 Intervention
Participants enrolled in the pharmacogenomics group will give a DNA (deoxyribonucleic acid) sample for immediate pharmacogenomic genotyping. Once the genotyping results are in, cancer doctors caring for each participant will have immediate access to clinical decision support based on the participant's genetic results and can make dosing decisions/changes to the participant's chemotherapy prescription.
Group II: Control GroupActive Control1 Intervention
Participants assigned to the control group will receive standard chemotherapy without their doctors receiving any genetic information based on the participants' pharmacogenetic results. DNA (Deoxyribonucleic acid) samples for participants in this group will be stored and tested for genotyping six months later after treatment (or earlier if the participant experiences side effects).

Find a Location

Who is running the clinical trial?

University of ChicagoLead Sponsor
997 Previous Clinical Trials
816,838 Total Patients Enrolled
Peter O'Donnell, MDPrincipal InvestigatorUniversity of Chicago
1 Previous Clinical Trials
1,000 Total Patients Enrolled
Peter H. O'Donnell, MDPrincipal InvestigatorUniversity of Chicago

Media Library

Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS) (Genetic Testing) Clinical Trial Eligibility Overview. Trial Name: NCT04541381 — N/A
Head and Neck Cancers Research Study Groups: Pharmacogenomics Group, Control Group
Head and Neck Cancers Clinical Trial 2023: Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS) Highlights & Side Effects. Trial Name: NCT04541381 — N/A
Pharmacogenomics (PGx) Testing and Genomics Prescribing Information (GPS) (Genetic Testing) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04541381 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the upper limit of individuals engaged in this clinical experiment?

"Affirmative. The information hosted on clinicaltrials.gov confirms that this medical investigation is actively recruiting participants, having been posted on February 7th 2022 and most recently updated October 20th 2022. Over 860 patients must be recruited from just one site."

Answered by AI

Is registration for this research endeavor open at the present moment?

"Affirmative. The clinical trial registry on clinicialtrials.gov confirms that this research, which was originally posted on February 7th 2022, is actively enrolling participants. 860 patients are required for the sole location of this study."

Answered by AI

What are the chief goals of this medical experiment?

"This ongoing clinical trial, with a planned duration of 15 months, aims to assess the Grade 3 or Higher Toxicity (Co-Primary Endpoint). Secondary metrics such as Response Rate, Overall Survival, and Progression Free Survival will also be measured based on radiographic evaluation."

Answered by AI
~539 spots leftby Oct 2027