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

Cancer Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05583422
• Other study ID #: UMCC 2022.062
• Secondary ID: HUM00213709
• Status: Recruiting
• Phase: N/A
• Start date: August 18, 2023
• Est. completion date: December 2025

Study information

• Verified date: January 2024
• Source: University of Michigan Rogel Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 96
• Est. completion date: December 2025
• Est. primary completion date: December 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

Genetic:
• DPYD or UGT1A1 variants
any CLIA certified lab can be used for confirmatory testing after patients have been identified through Michigan Genomics Initiative (MGI)

Locations

Country	Name	City	State
United States	University of Michigan Rogel Cancer Center	Ann Arbor	Michigan

Sponsors (1)

Lead Sponsor	Collaborator
University of Michigan Rogel Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Comparison of grade 3 or higher AEs and SAEs	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	five months from treatment initiation
Secondary	Comparison of PGx genotypes to MGI genotypes	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	five months from treatment initiation
Secondary	Comparison of rates of dose reductions	A decrease in dose of standard of care treatment by >10% of the dose administered for the prior cycle	five months from treatment initiation
Secondary	Comparison of treatment cycle delays	Any prolongation of the initiation of the following scheduled treatment cycle due to toxicity as documented by the patient's medical team	five months from treatment initiation
Secondary	Comparison of treatment discontinuation	Any discontinuation due to clinician-documented toxicity	five months from treatment initiation
Secondary	Clinician acceptance of supportive care pharmacogenetics	Evaluation of the amount of new prescriptions written with identified genetic interactions	6 months post first standard of care treatment