Status:
UNKNOWN
Identifying Novel Variants in the DPYD Gene in Patients of Non-Western Descent
Lead Sponsor:
Leiden University Medical Center
Collaborating Sponsors:
The Netherlands Cancer Institute
Erasmus Medical Center
Conditions:
Neoplasms
Eligibility:
All Genders
18+ years
Brief Summary
This is a observational, multicenter study to identify novel variants of the DPYD gene which are possible deleterious in patients of non-Western descent.
Detailed Description
Research has shown that DPYD-guided dose-individualization based on 4 DPYD variants (DPYD\*2A, c.1236G\>A, c.2846A\>T and c.1679T\>G) can significantly reduce severe fluoropyrimidine-related toxicity....
Eligibility Criteria
Inclusion
- Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient's best interest
- Patients need to be self-declared non-Western
- Age 18 years and older
- Able and willing to give written informed consent
- WHO performance status of 0, 1 or 2
- Life expectancy of at least 12 weeks
- Able and willing to undergo blood sampling for study related analysis
- Adequate baseline patient characteristics (complete blood count, hepatic function which involves serum bilirubin, ASAT, ALAT, and renal function)
Exclusion
- Prior treatment with fluoropyrimidines
- Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient's safety
Key Trial Info
Start Date :
March 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
August 1 2022
Estimated Enrollment :
600 Patients enrolled
Trial Details
Trial ID
NCT04300361
Start Date
March 1 2020
End Date
August 1 2022
Last Update
March 9 2020
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