Diagnosis of basal cell carcinoma in the head and neck by dermoscopy and handheld reflectance confocal microscopy.

Not Applicable

Completed

Conditions: <p>basal cell carcinoma, diagnostics, dermoscopy, confocal microscopy, rcm</p>
10040900

Registration Number: NL-OMON27500

Lead Sponsor: etherlands Cancer Institute

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 258

Inclusion Criteria

1. Patients with suspected primary BCC on naked-eye examination as assessed by an experienced board-certified dermatologist.
2. Lesion localization in the head and neck (i.e. supraclavicular/above the 7th cervical vertebrae) with an indication for surgical treatment.
3. Anatomic localization of the lesion allows evaluation by HH-RCM and dermoscopy.
4. Patient age ¡Ý 18 years and is willing and able to comply with the study requirements and give written informed consent

Exclusion Criteria

1. Recurrent BCC, defined as a suspected BCC localized within 5mm from the site of previously surgically or non-surgically treated BCC.
2. Suspected BCC localized outside the head and neck (i.e. infraclavicular/below the 7th cervical vertebrae).
3. Anatomical localization of lesion not accessible by HH-RCM or dermoscopic imaging.
4. Patients with genetic syndromes with increased risk of developing BCCs (e.g. Gorlin-Goltz, xeroderma pigmentosa).
5. Patients being treated by immunosuppressive medication.
6. Lesions on previously radiated skin.
7. Patients not eligible for surgical excision due to co-morbidity/ patient refusal.

Study & Design

Study Type: Observational non invasive

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>1. The diagnostic accuracy of dermoscopy and HH-RCM in diagnosing and subtyping (Table 1) of BCC in the head and neck, compared to the current diagnostic reference standard (3mm punch biopsy).<br>2. Rate of over- and understaging of BCC subtypes in the head and neck by dermoscopy (index), HH-RCM (index), and punch biopsy (control) compared to the outcome of the final excisional specimen (reference standard).</p>

Secondary Outcome Measures

Name	Time	Method
<p>1. Reliability of naked-eye examination in the diagnosing and subtyping of BCC in the head and neck.<br>2. Diagnostic value of established dermoscopic and RCM criteria in the differentiation of BCC subtypes in the head and neck.<br>3. Inter- and intraobserver agreement of the dermoscopic and HH-RCM criteria, diagnosis and subtyping of BCC.</p>