Ex-vivo confocal microscopy: diagnostic accuracy, acceptability & feasibility for skin cancers and inflammatory dermatoses
- Conditions
- skin cancerinflammatory dermatosesCancer - Non melanoma skin cancerCancer - Malignant melanomaInflammatory and Immune System - Autoimmune diseases
- Registration Number
- ACTRN12623000629639
- Lead Sponsor
- Royal Prince Alfred Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 196
Aged 18 years or older
-Have a clinician-identified lesion that is consistent with basal cell carcinoma ( BCC), squamous cell carcinoma (SCC), inflammatory dermatosis (including but not limited to dermatitis, psoriasis, rosacea, lichen planus, cutaneous lupus, etc.), or biopsy-proven lentigo maligna (LM) with a residual pigmented macule.
-Have a lesion needing biopsy or excision as per clinical evaluation, that is to be collected by punch biopsy, elliptical excision, excision with margin control or shave excision depending on the lesion itself
-Be willing and capable to provide informed consent and be willing to participate and comply with the study requirements.
-Be unwilling or unable to provide informed consent or participate in the study
-Be deemed unsuitable by the treating clinician
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To determine the accuracy (ie composite sensitivity, specificity, positive predictive value and negative predictive value) of fusion ex vivo confocal microscopy (fevCM) in keratinocyte cancers, melanocytic lesions and inflammatory dermatoses compared to routine histological sections (frozen and paraffin sections).<br><br>[ Assessed post tissue excision]
- Secondary Outcome Measures
Name Time Method To determine fevCM processing time [ Assessed at the time of fevCM processing post tissue excision]