Safety of topical 5-FU cream in patients carrying a clinically relevant DPYD variant

Safety of topical 5-FU cream in patients carrying a clinically relevant DPYD variant - DPYDIX

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON54797

Enrollment

550

Registered

2019-10-03

Start date

2019-10-23

Completion date

Unknown

Last updated

2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Actinic keratosis damage from sunlight

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Age >= 18 years - Able to understand the written information and able to give informed consent - Planned treatment with topical 5-FU cream (Efudix) for any indication - Possibility to take photos of the treatment area at the designated times and send them digitally

Exclusion criteria

Exclusion criteria: - Known allergy to (components of) 5-FU cream - Pregnancy, breast-feeding, active child wish - Concomitant use of systemic retinoids - Patients with known substance abuse, psychotic disorders, and/or other diseases expected to interfere with study or the patient*s safety in the opinion of the treating physician

Design outcomes

Primary

Measure	Time frame
Primary Objective is to prospectively study if patients carrying clinically relevant DPYD variants (DPYD2A, DPYD7, c.2846A>T, c.1236G>A/HapB3, c.1679T>G) are more at risk for developing moderate/severe vesicles or bullae with 5-FU cream	—

Secondary

Measure	Time frame
Secondary Objectives: • To assess the pharmacokinetic profile of 5-FU and the metabolites in patients treated with 5-FU cream. • To assess if the time of onset of adverse events in patients with a clinically relevant DPYD variant is earlier in than in patients without a DPYD variant. • To assess if patients carrying a clinically relevant DPYD variant are more at risk to develop severe toxicity. • To assess if clinically complete tumour response at 3 months is different between pa-tients with and without a clinically relevant DPYD variant. • To determine in patients with actinic keratosis the risks for developing basal cell carci-noma and/or squamous cell carcinoma (SCC).	—

Measure

Time frame

Secondary Objectives: • To assess the pharmacokinetic profile of 5-FU and the metabolites in patients treated with 5-FU cream. • To assess if the time of onset of adverse events in patients with a clinically relevant DPYD variant is earlier in than in patients without a DPYD variant. • To assess if patients carrying a clinically relevant DPYD variant are more at risk to develop severe toxicity. • To assess if clinically complete tumour response at 3 months is different between pa-tients with and without a clinically relevant DPYD variant. • To determine in patients with actinic keratosis the risks for developing basal cell carci-noma and/or squamous cell carcinoma (SCC).

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Countries

Netherlands

Outcome results