Clinical Trial: One-stop-shop Study for Treatment of Basal Cell Carcinoma Using Reflectance Confocal Microscopy

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Treatment of Basal Cell Carcinoma Using a One-stop-shop With Reflectance Confocal Microscopy: a Randomized Controlled Multicenter Trial

Brief Summary: The purpose of this study is to assess the efficacy and safety of the one-stop-shop concept, using real-time in vivo reflectance confocal microscopy as diagnostic tool, prior to surgical management of new primary basal cell carcinoma

Detailed Summary:

Basal cell carcinoma (BCC) is the most common cancer diagnosed in white populations worldwide. The rising incidence of BCCs is becoming a major worldwide public health problem (1,11). Between 1973 and 2009, the European standardized rate quadrupled from 40 to 165 per 100,000 person-years for men and from 34 to 157 for women, most probably as a result of more intensive UV exposure (12). This is supported by previous published epidemiological literature indicating that ultraviolet radiation is an important risk factor for BCC with a significant increase among outdoor workers (13,14). Despite the low mortality from BCC, multiple and recurring tumors confer a high morbidity and considerable burden for health care providers and health budgets. Although BCC does not seem to have a high effect on patients' quality of life, patients suffering from BCC are definitely interested in efficacy, low recurrence rates and cosmetic outcome of their therapies.(15). Meanwhile resources available at hospitals have not increased proportionally and therefore optimizing effectiveness of present treatment modalities in daily dermatologic practice is mandatory (16).

Clinically, BCC are characterized by small, translucent, or pearly papules, with raised teleangiectatic edges (17) . Most of the BCC occur in sun-exposed skin of the head and neck area (18,19). Sensitivity and positive predictive value for the clinical diagnosing of BCC by dermatologists has been reported to be 95.4% and 85.9%, respectively (20). However, dividing between BCC subtypes is not always possible upon clinical assessment. To date, histological analysis of punch biopsy remains the golden standard to confirm the clinical diagnosis of BCCs and dividing between the following subtypes: nodular (nBCC), micronodular (mnBCC), infiltrating (iBCC) and superficial (sBCC) (10). Of those, nBCC and sBCC have a less aggressive growth patt
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Current Primary Outcome: 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. [ Time Frame: Within the first week after surgical excision of suspected BCC lesion ]

Assessment will be performed by an experienced board certified pathologist. The number of incomplete excisions will be compared between study- and control group.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]
    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 ]
    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.


Original Secondary Outcome: Same as current

Information By: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Dates:
Date Received: November 1, 2014
Date Started: January 2015
Date Completion:
Last Updated: April 12, 2016
Last Verified: April 2016