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NCT05583422 · ClinicalTrials.gov registry record
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy
A clinical trial, sponsored by University of Michigan Rogel Cancer Center.
- Completed
- Registry status
- 16
- Enrollment target
NCT05583422: Completed study, sponsored by University of Michigan Rogel Cancer Center.
NCT05583422 is a clinical trial that has completed, run by University of Michigan Rogel Cancer Center. The registered enrollment target is 16 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05583422 has completed, sponsored by University of Michigan Rogel Cancer Center.
- COMPLETED
- Registry status
- 16 participants
- Enrollment target
Study 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.
Primary Outcome
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
Interventions
- GENETIC DPYD or UGT1A1 variants
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 16 participants |
| Start Date | 2023-08-18 |
| Est. Completion | 2024-06-17 |
What the finished NCT05583422 record still lists
NCT05583422 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 16 participants, a relatively small participant target.
The record links to 0 conditions, and to 1 intervention - of which DPYD or UGT1A1 variants is the first listed.
NCT05583422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05583422 about?
NCT05583422 is a clinical study titled "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...
What is the current status of trial NCT05583422?
This trial is currently completed. The enrollment target is 16 participants. The study started on 2023-08-18. Estimated completion is 2024-06-17.
What interventions are being tested in trial NCT05583422?
The interventions under investigation include: DPYD or UGT1A1 variants (GENETIC).
Who is sponsoring clinical trial NCT05583422?
This trial is sponsored by University of Michigan Rogel Cancer Center, which has 292 total clinical trials registered on ClinicalTrials.gov.
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