Please select the arm or intervention descriptions that belong to the clinical trial below.
Title: In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial
Brief Summary: Skin cancer is the most common cancer and its incidence is increasing rapidly. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.


Options:
A: Arm Label: Vismodegib 150 mg; Type: EXPERIMENTAL; Interventions: Drug: Vismodegib 150 mg | Intervention Type: DRUG; Name: Vismodegib 150 mg; Assigned to Arm(s): Vismodegib 150 mg
B: Intervention Type: DRUG; Name: imiquimod; Assigned to Arm(s): N/A | Intervention Type: PROCEDURE; Name: conventional surgery; Assigned to Arm(s): N/A
C: Arm Label: Standard of care procedure; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Punch biopsy, Procedure: Surgical excision | Arm Label: Reflectance confocal microscopy (RCM); Type: EXPERIMENTAL; Interventions: Device: Reflectance confocal microscopy, Procedure: Surgical excision | Intervention Type: DEVICE; Name: Reflectance confocal microscopy; Assigned to Arm(s): Reflectance confocal microscopy (RCM) | Intervention Type: PROCEDURE; Name: Punch biopsy; Assigned to Arm(s): Standard of care procedure | Intervention Type: PROCEDURE; Name: Surgical excision; Assigned to Arm(s): Reflectance confocal microscopy (RCM), Standard of care procedure
D: Arm Label: RCM-OSS procedure; Type: EXPERIMENTAL; Interventions: Device: Reflectance confocal microscopy, Procedure: Surgical excision | Arm Label: Standard of care procedure; Type: ACTIVE_COMPARATOR; Interventions: Procedure: Punch biopsy, Procedure: Surgical excision | Intervention Type: DEVICE; Name: Reflectance confocal microscopy; Assigned to Arm(s): RCM-OSS procedure | Intervention Type: PROCEDURE; Name: Punch biopsy; Assigned to Arm(s): Standard of care procedure | Intervention Type: PROCEDURE; Name: Surgical excision; Assigned to Arm(s): RCM-OSS procedure, Standard of care procedure

Answer: C