CancerNCT05583422
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy
An observational study of Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- DPYD or UGT1A1 variants
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Aug 2023to 17 Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Age > 18 years
- Prospectively enrolled cases:
- 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
- The ability to understand and the willingness to sign a written informed consent.
- Retrospective cases:
- Confirmed actionable DPYD phenotype before treatment with systemic FP OR confirmed actionable UGT1A1 phenotype before treatment with irinotecan
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- Clinician initiated dose reduction of the fluoropyrimidine or irinotecan therapy based upon genotype result
- Retrospective controls:
- Suspected actionable DPYD phenotype per MGI and treatment with systemic FP OR suspected actionable UGT1A1 phenotype per MGI and treatment with irinotecan
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Rogel Cancer Center
Ann Arbor, Michigan, 48109
About this study
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
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.
Read the 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).
- Conditions
- Cancer
- Being tested
- DPYD or UGT1A1 variants
- Keywords
- DPYD, UGT1A1
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DPYD or UGT1A1 variantsGenetic
any CLIA certified lab can be used for confirmatory testing after patients have been identified through Michigan Genomics Initiative (MGI)
| Study group | Role | What they receive |
|---|---|---|
| Cases | 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. Receives: Genetic: DPYD or UGT1A1 variants | |
| Controls | This arm will be compiled of all retrospective patients where genetic information was not known prior to receiving treatment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: five months from treatment initiation
Secondary outcomes (5)
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
Measured: five months from treatment initiation
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
Measured: five months from treatment initiation
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
Measured: five months from treatment initiation
Comparison of treatment discontinuation
Any discontinuation due to clinician-documented toxicity
Measured: five months from treatment initiation
Clinician acceptance of supportive care pharmacogenetics
Evaluation of the amount of new prescriptions written with identified genetic interactions
Measured: 6 months post first standard of care treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Oct 2022
- Study start18 Aug 2023
- Primary completion17 Jun 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Amy Pasternak, Principal investigator, University of Michigan Rogel Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05583422
- Sponsor's protocol ID
- UMCC 2022.062
- Other IDs
- HUM00213709
- Status last verified
- May 2025
- First submitted
- 13 Oct 2022
- Last updated
- 11 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05583422
- Acronym / sponsor ID
- UMCC 2022.062
- Conditions
- Cancer
- Keywords
- DPYD, UGT1A1
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 18 Aug 2023 (actual)
- Primary completion
- 17 Jun 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 17 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | Genetic: DPYD or UGT1A1 variantsThis 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. |
| Controls | – | –This arm will be compiled of all retrospective patients where genetic information was not known prior to receiving treatment. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- Age > 18 years
- Prospectively enrolled cases:
- 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
- The ability to understand and the willingness to sign a written informed consent.
- Retrospective cases:
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DPYD or UGT1A1 variantsany CLIA certified lab can be used for confirmatory testing after patients have been identified through Michigan Genomics Initiative (MGI) | Genetic | Cases |
Primary outcome
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
5 secondary outcomes
Comparison of PGx genotypes to MGI genotypes
Time frame: five months from treatment initiation
Comparison of rates of dose reductions
Time frame: five months from treatment initiation
Comparison of treatment cycle delays
Time frame: five months from treatment initiation
Comparison of treatment discontinuation
Time frame: five months from treatment initiation
Clinician acceptance of supportive care pharmacogenetics
Time frame: 6 months post first standard of care treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Amy Pasternak principal investigator
University of Michigan Rogel Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by University of Michigan Rogel Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of grade 3 or higher AEs and SAEs (time frame: five months from treatment initiation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2025.