In Vivo Reflectance Confocal Microscopy, a Novel Non-invasive Tool for Diagnosing Skin Cancer - A Randomized Controlled Trial

INTRODUCTION AND RATIONALE:

Skin cancer is the most common cancer and its incidence is increasing rapidly in Western countries. In the Netherlands the registry of skin cancer is poor, however based on recent literature and guidelines the investigators estimate the number of new malignant skin tumors and the precursor actinic keratosis (AK) in 2015 at around 235,278, having a major impact on the health care system. Moreover, it is predicted that numbers of skin cancer will rise with 4.5-8% per year, depending on the type of skin cancer. Skin cancer comprises melanoma and non-melanoma skin cancer (NMSC: basal cell carcinoma (BCC), squamous cell carcinoma (SCC) and its precursors actinic keratosis (AK) and Bowen disease). In case of suspicion on NMSC, at present, the pathological examination of a biopsy is the gold standard. In case of clinical suspicion on AK, the diagnosis is made à vue, without pathological confirmation. In the United States, already in 2003, skin cancer was found to be among the most costly of all cancers to treat, thus, it is evident that skin cancer places an enormous burden on western healthcare systems with increasing costs. As BCC is the most common skin cancer (about 75% of all skin cancers) with an estimated incidence of 51,000 new tumors in 2015, this study will focus on this skin cancer type.

HEALTH CARE EFFICIENCY PROBLEM:

As described above, the incidences of the various malignant skin tumours are increasing dramatically. The rising number of skin cancer may result in long waiting lists for consultation at departments for dermatological care and in increasing health care costs. In case of suspicion on skin cancer it is of utmost importance to diagnose and treat in an early phase, preferable in a patient friendly manner. With the implementation of reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis is assessed at the first consultation and the patient can be treated instantly. A second consultation for explaining the diagnosis is than not necessary, which time can then be used for other new patients. Also, with the conventional diagnostic procedure (pathological investigation of a skin biopsy) the investigators experience in 29% of the cases a sample error, so the BCC subtype is not correctly identified, and as treatment depends on BCC subtype many patients need a subsequent treatment because of treatment failure or recurrence. Also for pathologists, to examine skin tumor after skin tumor is not that efficient and challenging. More pathologists are needed if there will not be other diagnostic techniques in the future. RCM will also, not unimportantly, lower the costs for diagnosing skin cancer.

USUAL CARE: