|- candidate number||26495|
|- NTR Number||NTR6502|
|- ISRCTN||ISRCTN no longer applicable|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||18-jan-2017|
|- Secondary IDs||N17BCC Interne code|
|- Public Title||Noninvasive diagnostics of basal cell carcinoma in the head and neck by dermoscopy and handheld reflectance confocal microscopy.|
|- Scientific Title||Noninvasive diagnostics and subtyping of basal cell carcinoma in the head and neck by dermoscopy and handheld reflectance confocal microscopy.|
|- Healt Condition(s) or Problem(s) studied||Basal cell carcinoma, Dermoscopy|
|- 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.
|- mec approval received||yes|
|- multicenter trial||no|
|- Type||Single arm|
|- planned startdate ||1-feb-2017|
|- planned closingdate||1-feb-2019|
|- Target number of participants||258|
|- 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 overview and macroscopic lesion photography by coordinating investigator.
II. Dermoscopic imaging by coordinating investigator.
III. HH-RCM assessment by coordinating investigator.
IV. 3mm punch biopsy by coordinating investigator
V. Punch biopsy specimen evaluation by a board-certified pathologist blinded to clinical/dermoscopic/HH-RCM outcomes.
a. BCC positive: to VI
b. BCC negative: 6 month follow-up to minimize chance of false negatives.
VI. Therapeutic excision with margin based on current Dutch BCC guidelines by a board-certified dermatologist or oncologic head and neck surgeon, followed by evaluation by a board-certified pathologist blinded to clinical/ dermoscopic/ HH-RCM/ punch biopsy outcomes.
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:
a. Expert evaluation of outcomes II and III blinded to the outcome of the diagnostic reference standard and excisional outcomes.
b. Blinded evaluation of the histopathologic outcomes by a second pathologist. In case of discordance this will be solved by discussion/third pathologist.
|- Primary outcome||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 outcome||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.
|- Timepoints||Lesions with a negative BCC punch biopsy outcome will be re-evaluated at 6 months. All other research related data will be collected on the day of initial consultation or during standard of care.|
|- Trial web site|
|- CONTACT FOR PUBLIC QUERIES|| Yannick Elshot|
|- CONTACT for SCIENTIFIC QUERIES|| Yannick Elshot|
|- Sponsor/Initiator ||Netherlands Cancer Institute - Antoni van Leeuwenhoek Hospital (NKI AVL) |
(Source(s) of Monetary or Material Support)
|- Brief summary|
|- Main changes (audit trail)|
|- RECORD||18-jan-2017 - 10-jul-2017|