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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON27500

Enrollment

258

Registered

2017-01-18

Start date

2017-04-12

Completion date

Unknown

Last updated

2024-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

basal cell carcinoma, diagnostics, dermoscopy, confocal microscopy, rcm

Interventions

Consecutive patients with suspected BCC in the head and neck on naked-eye examination will be prospectively enrolled during regular consultation. Study group procedures : I. Standardized skin overvie

In case Mohs surgery is indicated, tumor debulking will be performed during surgery for conventional histopathological analysis in addition to evaluation of the Mohs slides. VII. Additional evaluation

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
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). 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).	—

Measure

Time frame

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). 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).

—

Secondary

Measure	Time frame
1. Reliability of naked-eye examination in the diagnosing and subtyping of BCC in the head and neck. 2. Diagnostic value of established dermoscopic and RCM criteria in the differentiation of BCC subtypes in the head and neck. 3. Inter- and intraobserver agreement of the dermoscopic and HH-RCM criteria, diagnosis and subtyping of BCC.	—

Contacts

Public ContactYannick Elshot

y.elshot@nki.nl

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)