To hear about similar clinical trials, please enter your email below
Trial Title:
Evaluating a Pharmacogenetic Testing Panel in Patients Suspected to be at Increased Risk for Pharmacogenetics-related AEs While Receiving Fluoropyrimidine or Irinotecan Therapy
NCT ID:
NCT05583422
Condition:
Cancer
Conditions: Keywords:
DPYD
UGT1A1
Study type:
Interventional
Study phase:
N/A
Overall status:
Active, not recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Genetic
Intervention name:
DPYD or UGT1A1 variants
Description:
any CLIA certified lab can be used for confirmatory testing after patients have been
identified through Michigan Genomics Initiative (MGI)
Arm group label:
Cases
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of Michigan Rogel Cancer Center
Address:
City:
Ann Arbor
Zip:
48109
Country:
United States
Start date:
August 18, 2023
Completion date:
December 2025
Lead sponsor:
Agency:
University of Michigan Rogel Cancer Center
Agency class:
Other
Source:
University of Michigan Rogel Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05583422
