Clinical trial · Observational

Identifying Novel Variants in the DPYD Gene in Patients of Non-Western Descent

A Prospective, Multicenter, Observational Study to Identify Novel Deleterious Variants in the DPYD Gene in Patients of Non-Western Descent: The DPYD-NOW Study

NCT04300361CI-TRIAL-00043874DPYD-NOWunknownClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

This is a observational, multicenter study to identify novel variants of the DPYD gene which are possible deleterious in patients of non-Western descent.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Neoplasms	Neoplasm	ONTOLOGY_EXACT	0.90

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
Sequencing of DPYD gene	Genetic	—	UNRESOLVED

Design

Arms and outcomes

Arms (1)

label
Non-Western patients
description
Patients of non-Western descent with an indication for treatment with fluoropyrimidine-based chemotherapy. A patient is classified as non-Western if a one (1) of the parents or more than two (\>2) of the grand parents are of non-Western descent.
interventionNames
1. Genetic: Sequencing of DPYD gene

Primary outcomes (1)

measure
Presence of variants of the DPYD gene that are possibly associated with an increased risk of severe fluoropyrimidine-related toxicity in patients of non-Western descent
timeFrame
Patients will be followed for the first 2 cycles (each cycle is 28 days).

Secondary outcomes (4)

measure
DPD enzyme activity of patients carrying a novel DPYD variant compared to wildtype patients measured in peripheral blood mononuclear cells (PBMCs)
timeFrame
Through study completion, an average of 2 years

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 18 Years

Show eligibility criteria text

Inclusion Criteria:

* 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 Criteria:

* 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

References

Publications (0)

Data not yet available

No reference posted for this study.