Treatment of basal cell carcinoma using a one-stop-shop with reflectance confocal microscopy: a randomized controlled multicenter trial

Completed

Conditions: Skin cancer
BCC
10040900

Registration Number: NL-OMON40630

Lead Sponsor: Academisch Medisch Centrum

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 76

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

* 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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Compare the OSS concept with RCM in the surgical treatment of BCCs with current<br /><br>standard of care, by assessing incomplete surgical excision on the final<br /><br>pathology report, defined by residual histopathological BCC features in HE<br /><br>stained sections of surgically excised specimen.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>To assess the accuracy (sensitivity and specificity) of diagnosing BCC by<br /><br>comparing RCM with punch biopsy as diagnostic tools.<br /><br>To assess the accuracy (sensitivity and specificity) of BCC subtyping by<br /><br>comparing RCM diagnosis, including inter- and intra-observer agreement, with<br /><br>final pathology report.<br /><br>To compare the following items of the OSS concept with RCM in the surgical<br /><br>treatment of BCCs with current standard of care: 1. patient satisfaction of the<br /><br>RCM OSS concept for the surgical treatment of BCCs. 2. throughput time,<br /><br>defined by the time between arrival at consultation until end of surgical<br /><br>treatment at our outpatient clinic. </p><br>