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NCT Number: NCT05583422

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

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.

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Key information

Conditions

Cancer Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Michigan Rogel Cancer Center

Ann Arbor, Michigan, 48109, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

DPYD or UGT1A1 variants

Genetic

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

Primary outcomes

  1. Comparison of grade 3 or higher AEs and SAEs

    Time frame: five months from treatment initiation

    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

Secondary outcomes

  1. Comparison of PGx genotypes to MGI genotypes

    Time frame: five months from treatment initiation

    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

  2. Comparison of rates of dose reductions

    Time frame: five months from treatment initiation

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

  3. Comparison of treatment cycle delays

    Time frame: five months from treatment initiation

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

  4. Comparison of treatment discontinuation

    Time frame: five months from treatment initiation

    Any discontinuation due to clinician-documented toxicity

  5. Clinician acceptance of supportive care pharmacogenetics

    Time frame: 6 months post first standard of care treatment

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

Sponsors and collaborators

Lead sponsor

University of Michigan Rogel Cancer Center

Other

Registry information

Official study 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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 17, 2022
Registry last updated
May 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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