Antineoplastic Agents

All Drugs and Chemicals

Irinotecan

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.

This arm will be compiled of all retrospective patients where genetic information was not known prior to receiving treatment.

any CLIA certified lab can be used for confirmatory testing after patients have been identified through Michigan Genomics Initiative (MGI)

DPYD or UGT1A1 variants

Cancer AnswerLine

Amy Pasternak

This study will be evaluating patients suspected to carry DPYD or UGT1A1 variants based off of Michigan Genomics Initiative (MGI) results. Standard of care treatment will be initiated with either Fluoropyrimidine or Irinotecan therapy. Retrospective collection of treatment related AEs and SAEs, dose delays, dose reductions, and treatment discontinuations will be completed.

Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy

Evaluating the Uptake and Impact of a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy

Compare rates of grade 3 or higher AEs and SAEs to fluoropyrimidine or irinotecan treatment between subjects with confirmed DPYD or UGT1A1 variants before chemotherapy treatment to retrospective matched controls without confirmatory PGx testing

clinical genotypes and MGI genotypes for participants will be considered concordant if they identify the same DPYD or UGT1A1 variant and discordant if they do not

A decrease in dose of standard of care treatment by \>10% of the dose administered for the prior cycle

Any prolongation of the initiation of the following scheduled treatment cycle due to toxicity as documented by the patient's medical team

Any discontinuation due to clinician-documented toxicity

Evaluation of the amount of new prescriptions written with identified genetic interactions

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy	NCT05583422	Cancer	DPYD or UGT1A1 ...	18 Years -	University of Michigan Rogel Cancer Center
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy	NCT05583422	Cancer	DPYD or UGT1A1 ...	18 Years -	University of Michigan Rogel Cancer Center
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy	NCT05583422	Cancer	DPYD or UGT1A1 ...	18 Years -	University of Michigan Rogel Cancer Center

Spots Global Cancer Trial Database for dpyd or ugt1a1 variants