Clinical Trial: Reflectance Confocal Microscopy in Basal Cell Carcinoma

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional

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

Brief Summary:

Skin cancer is the most common cancer and its incidence is increasing rapidly. 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. 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). As BCC is the most common skin cancer type with an estimated incidence of 51,000 new tumors in 2015 (The Netherlands), this study will focus on this skin cancer type. In case of suspicion on BCC, at present, the pathological examination of a biopsy is the gold standard for diagnosing a BCC. With the implementation of non invasive diagnosis by reflectance confocal microscopy (RCM) in routine patient care settings the diagnosis can be assessed at the first consultation in a non-invasive way and the patient can be treated instantly.

Overall, the aim of this study is to investigate whether reflectance confocal microscopy can correctly identify the subtype of basal cell carcinoma.

Study design: Randomized controlled trail. Comparison with usual care: punch biopsy and excision.


Detailed Summary:

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 implementat
Sponsor: Radboud University

Current Primary Outcome: The number of correctly identified basal cell carcinoma and the subtype by Reflectance confocal microscopy validated by histopathological examination of the excision specimen [ Time Frame: Through study completion, an average of 3 years ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Quality of life (Qol) [ Time Frame: Through study completion, an average of 3 years ]
    VAS (Visual analogue scale)
  • Cost effectiveness of Reflectance confocal microscopy as diagnostic tool to diagnose basal cell carcinoma [ Time Frame: Through study completion, an average of 3 years ]
    Productivity Cost Questionnaire (IMCQ, generic instrument for measuring medical costs)
  • Quality Adjusted Live Years (QALY's) [ Time Frame: Through study completion, an average of 3 years ]
    EQ-5D-5L health questionnaire


Original Secondary Outcome: Same as current

Information By: Radboud University

Dates:
Date Received: November 10, 2015
Date Started: January 2016
Date Completion:
Last Updated: October 12, 2016
Last Verified: October 2016