Basal cell carcinoma (BCC)
Conditions
Interventions
Conventional surgical excision under local anesthetics
Sponsors
Academic Medical Center (AMC) Amsterdam
Eligibility
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 12h00 AM will be eligible to participate Patient is willing and able to give written informed consent 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 a history of allergy to local anesthesia Unavailability within the following 6 weeks (for example due to holiday or sports) Patients not competent to understand the procedures involved
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between one stop shop using reflectance confocal microscopy in the surgical treatment of BCC and current standard of care using punch biopsy, by assessing incomplete surgical excision on the final pathology report. | — |
Secondary
| Measure | Time frame |
|---|---|
| Comparison of the diagnostic accuracy (sensitivity and specificity) between RCM and punch biopsy in both diagnosing and subtyping BCCs [ Time Frame: Within the first week after surgical excision of suspected BCC lesion ] [ Designated as safety issue: No ] Sensitivity and specificity of RCM for diagnosing and subtyping BCC, will be separately analyzed by comparing RCM diagnosis and subtype with final pathology reports of the study group. This will be performed by using unidentifiable saved RCM images of all included lesions of the study group. Comparison of patient satisfaction between study group and standard of care (control) group by using a standardized web-based questionnaire for patient reported outcome in the management of skin diseases (www.huidvragen.info) [ Time Frame: As assessed at the post-operative visit 3 months after surgical excision ] [ Designated as safety issue: No ] An adjusted version of this web-based questionnaire has previously been published to assess patient satisfaction among patients suffering from psoriasis (van Cranenburgh OD et al. Satisfaction with treatment among patients with psoriasis: a web-based survey study. Br J Dermatol. 2013 Aug;169(2):398-405). The outcome of the questionnaire will be compared between study- and control group. | — |
Contacts
Public ContactDaniel J. Kadouch
Academic Medical Center (AMC) - Department of dermatology
Outcome results
None listed