Clinical trial NCT05583422: Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: DPYD
UGT1A1
Lead sponsor: University of Michigan Rogel Cancer Center
Sponsor class: OTHER
First posted: 2022-10-17
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: Trial was registered as interventional as patients could be enrolled prospectively or retrospectively. Based on data received 2/3/2025, all 16 enrolled cases ended up being identified retrospectively. As the study is now considered to be only retrospective, the record has been updated as not an applicable clinical trial (ACT).

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years
* Prospectively enrolled cases:

A. Suspected to carry an actionable DPYD phenotype per MGI and initiating treatment with systemic FP OR suspected to carry an actionable UGT1A1 phenotype per MGI and initiating treatment with irinotecan for cancer

B. The ability to understand and the willingness to sign a written informed consent.

* Retrospective cases:

A. Confirmed actionable DPYD phenotype before treatment with systemic FP OR confirmed actionable UGT1A1 phenotype before treatment with irinotecan

B. Clinician initiated dose reduction of the fluoropyrimidine or irinotecan therapy based upon genotype result

* Retrospective controls:

A. Suspected actionable DPYD phenotype per MGI and treatment with systemic FP OR suspected actionable UGT1A1 phenotype per MGI and treatment with irinotecan

Exclusion Criteria:

* For prospective cases, prior treatment with systemic FP if suspected to carry an actionable DPYD phenotype
* For prospective cases, prior treatment with irinotecan if suspected to carry an actionable UGT1A1 phenotype
* For prospective cases, inability to understand consent or make health-related decisions
* History of allogeneic bone marrow transplant prior to genotype testing
* History of liver transplant

Primary outcomes:
measure: Comparison of grade 3 or higher AEs and SAEs
timeFrame: five months from treatment initiation
Secondary outcomes:
measure: Comparison of PGx genotypes to MGI genotypes
timeFrame: five months from treatment initiation
measure: Comparison of rates of dose reductions
timeFrame: five months from treatment initiation
measure: Comparison of treatment cycle delays
timeFrame: five months from treatment initiation
measure: Comparison of treatment discontinuation
timeFrame: five months from treatment initiation
measure: Clinician acceptance of supportive care pharmacogenetics
timeFrame: 6 months post first standard of care treatment
Other outcomes:
Locations:
city: Ann Arbor
country: United States
facility: University of Michigan Rogel Cancer Center
state: Michigan
Study officials:
affiliation: University of Michigan Rogel Cancer Center
name: Amy Pasternak
role: PRINCIPAL_INVESTIGATOR
References: