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Pharmacogenetic Testing Panel
Pharmacogenetic Testing for Cancer Treatment Safety
N/A
Recruiting
Led By Amy Pasternak
Research Sponsored by University of Michigan Rogel Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up five months from treatment initiation
Awards & highlights
Study Summary
This trial will evaluate patients for gene variants, then treat them with standard care. AEs and SAEs, dose delays, reductions, and discontinuations will be recorded.
Who is the study for?
This trial is for adults with cancer who may have genetic variants (DPYD or UGT1A1) that could affect how they respond to chemotherapy drugs like Fluoropyrimidine or Irinotecan. Participants must understand and consent to the study. Those previously treated with these drugs, unable to consent, or with a history of certain transplants are excluded.Check my eligibility
What is being tested?
The study tests if patients' genetic makeup (specifically DPYD or UGT1A1 variants) influences side effects when treated with Fluoropyrimidine or Irinotecan. It involves looking back at past treatments and outcomes as well as monitoring new patients starting therapy.See study design
What are the potential side effects?
Potential side effects from Fluoropyrimidine and Irinotecan can include nausea, vomiting, diarrhea, low blood cell counts leading to increased infection risk, fatigue, hair loss, and liver toxicity. Genetic variations might make some individuals more susceptible.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months post first standard of care treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months post first standard of care treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Comparison of grade 3 or higher AEs and SAEs
Secondary outcome measures
Clinician acceptance of supportive care pharmacogenetics
Comparison of PGx genotypes to MGI genotypes
Comparison of rates of dose reductions
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: CasesExperimental Treatment1 Intervention
This arm will be compiled of prospectively recruited cases for confirmatory testing based on their suspected genotype per Michigan Genomics Initiative and patients who have been retrospectively identified as any patient who had clinical genotype testing and had a variant that was their clinician used to guide the chemotherapy treatment. Prospective patients will undergo confirmatory genetic testing by a CLIA lab and those results will be provided to the patients clinical team at that time.
Group II: ControlsActive Control1 Intervention
This arm will be compiled of all retrospective patients where genetic information was not known prior to receiving treatment.
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Who is running the clinical trial?
University of Michigan Rogel Cancer CenterLead Sponsor
294 Previous Clinical Trials
24,025 Total Patients Enrolled
Amy PasternakPrincipal InvestigatorUniversity of Michigan Rogel Cancer Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have had a liver transplant.I have been treated with FP due to a suspected DPYD gene issue.I am older than 18 years.I have been treated with irinotecan due to my specific genetic makeup.I am able to understand consent and make decisions about my health.My medication dose was reduced based on genetic test results.I have a specific genetic marker related to how my body processes certain cancer drugs.I can understand and am willing to sign the consent form.I am starting treatment for cancer with specific drugs and have been tested for certain genetic traits.My tests showed specific genetic traits before treatment with certain chemotherapy drugs.I have had a bone marrow transplant from another person before genetic testing.
Research Study Groups:
This trial has the following groups:- Group 1: Cases
- Group 2: Controls
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 there any opportunities for interested individuals to take part in this research?
"Contrary to what is indicated on clinicaltrials.gov, this study has concluded its search for candidates. Initially posted on November 1st 2022, the last edited date was October 13th 2022. Nevertheless, there are currently 486 other trials welcoming participants in various medical disciplines and locations."
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