Cancer (breastcancer colorectal cancer gastric cancer)
Conditions
Interventions
None listed
Sponsors
Leids Universitair Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: 1. Pathologically confirmed malignancy for which treatment with a fluoropyrimidine is considered to be in the patient*s best interest 2. Patients need to be self-declared non-Western 3. Age * 18 years 4. Able and willing to give written informed consent; 5. WHO performance status of 0, 1 or 2 6. Life expectancy of at least 12 weeks 7. Able and willing to undergo blood sampling for study related analysis 8. Adequate baseline patient characteristics (complete blood count, hepatic function which involves serum bilirubin, AST, ALT, and renal function)
Exclusion criteria
Exclusion criteria: 1. Prior treatment with fluoropyrimidines 2. Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint in this study is the identification of novel variants in the DPYD gene in patients of non-Western descent that are associated with the development of severe (grade * 3) fluoropyrimidine-related toxicity and a reduced DPD enzyme activity measured in PBMCs. | — |
Secondary
| Measure | Time frame |
|---|---|
| * The influence of novel DPYD variants on the variation in DPD enzyme activity measured in PBMCs. * The ability of the DPYD-varifier to predict if novel variants are deleterious * The frequencies of DPYD variants per ethnic origin * Exploration of additional genes related to severe fluoropyrimidine-related toxicity | — |
Countries
Netherlands
Outcome results
None listed