Clinical trial · Observational
Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines.
Implementation and Quality Assurance of DPYD-genotyping in Patients Treated With Fluoropyrimidines
NCT05266300CI-TRIAL-00061857completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The purpose of this study is to examine the benefits of a clinical implementation of a DPYD-genotype test to patients starting treatment with fluoropyrimidines (Fluorouracil (5-FU), capecitabine, tegafur).
Conditions
Conditions (8)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adverse Drug Event | — | UNRESOLVED | — |
| Bile Duct Cancer | Malignant Bile Duct Neoplasm | CURATED_BROADER | 0.80 |
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Colon Cancer | Malignant Colon Neoplasm | CURATED_EXACT | 0.92 |
| Gastric Cancer | Malignant Gastric Neoplasm | CURATED_BROADER | 0.80 |
| Oesophageal Cancer | — | UNRESOLVED | — |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Rectal Cancer | Malignant Rectal Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| DPYD genotype | Genetic | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Retrospective
- description
- Historic group. Patients treated in the historic control group did not receive DPYD-genotype before treatment with fluorouracil, capecitabine, tegafur. They received standard start doses of 5-FU, capecitabine, tegafur.
- label
- Prospective
- description
- Participants enrolled in the prospective group will give a blood sample for immediate DPYD genotyping. Once the results from these tests are in, the treating oncologist have immediate access to the participant's genetic test results and can make dosing decisions/changes to the participant's chemotherapy prescription. The recommended starting doses for 5-FU, capecitabine, tegafur are. No DPYD-gene variant = normal starting dose (100%) 1 DPYD-gene variant (heterozygous) = Reduced starting dose (50%) Homozygous for 1 DPYD variant or compound heterozygous (\>1 variants) = Treatment with 5-FU, capecitabine, tegafur is not recommended .
- interventionNames
- Genetic: DPYD genotype
Primary outcomes (1)
- measure
- Adverse events
- timeFrame
- Up to 6 months
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with cancer that are eligible for systemic treatment with 5-FU, capecitabine, or tegafur. Exclusion Criteria: * Patients that earlier have been treated with 5-FU, capecitabine, or tegafur
References
Publications (0)
Data not yet available
No reference posted for this study.