Skin cancer
Conditions
Interventions
I Study group: clinically suspected new primary BCC lesion will be diagnosed
and divided into subtypes using RCM imaging (Vivascope 1500
Lucid
Technologies, Henrietta, NY, USA) according to a standardized protocol. After
the diagnosis, excision of the BCC lesion with adequate margins will be
performed on the same day at the Departme
Sponsors
Academisch Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: * Patients with clinically suspected new primary BCC as assessed by an experienced board certified dermatologist * Patients seen at the outpatient clinic before 12.00 AM will be eligible to participate * Patient is willing and able to give written informed consent * Age >=18 * BCC lesion is suitable for conventional surgical excision under local anesthetics * BCC lesion is present since at least 1 month
Exclusion criteria
Exclusion criteria: * BCC lesion in a high-risk location of the face (H-zone and ears) * Contra-indication for conventional surgical excision (primary surgical closure seems not achievable) * Recurrent BCC lesion (BCC that has been previously unsuccessfully treated) * Macroscopic ulcerating BCC lesions (not feasible for RCM analysis due to technical reasons) * Patients with basal cell nevus syndrome * Patients treated with hedgehog inhibitor medication * Patients with a history of hypersensitivity to and/or allergy to local anesthesia * Unavailability within the following 6 weeks (for example due to holiday or sports) * Patients not competent to understand what the procedures involved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Compare the OSS concept with RCM in the surgical treatment of BCCs with current standard of care, by assessing incomplete surgical excision on the final pathology report, defined by residual histopathological BCC features in HE stained sections of surgically excised specimen. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the accuracy (sensitivity and specificity) of diagnosing BCC by comparing RCM with punch biopsy as diagnostic tools. To assess the accuracy (sensitivity and specificity) of BCC subtyping by comparing RCM diagnosis, including inter- and intra-observer agreement, with final pathology report. To compare the following items of the OSS concept with RCM in the surgical treatment of BCCs with current standard of care: 1. patient satisfaction of the RCM OSS concept for the surgical treatment of BCCs. 2. throughput time, defined by the time between arrival at consultation until end of surgical treatment at our outpatient clinic. | — |
Countries
Netherlands
Outcome results
None listed