Safety of topical 5-FU cream in patients carrying a clinically relevant DPYD variant
Recruiting
- Conditions
- Actinic keratosisdamage from sunlight10040900
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 550
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
- 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
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Objective is to prospectively study if patients carrying clinically<br /><br>relevant DPYD variants (DPYD*2A, DPYD*7, c.2846A>T, c.1236G>A/HapB3, c.1679T>G)<br /><br>are more at risk for developing moderate/severe vesicles or bullae with 5-FU<br /><br>cream</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Objectives:<br /><br>• To assess the pharmacokinetic profile of 5-FU and the metabolites in patients<br /><br>treated with 5-FU cream.<br /><br>• To assess if the time of onset of adverse events in patients with a<br /><br>clinically relevant DPYD variant is earlier in than in patients without a DPYD<br /><br>variant.<br /><br>• To assess if patients carrying a clinically relevant DPYD variant are more at<br /><br>risk to develop severe toxicity.<br /><br>• To assess if clinically complete tumour response at 3 months is different<br /><br>between pa-tients with and without a clinically relevant DPYD variant.<br /><br>• To determine in patients with actinic keratosis the risks for developing<br /><br>basal cell carci-noma and/or squamous cell carcinoma (SCC).</p><br>