Nanocytology Test to Evaluate Skin Cancer in High Risk Patients
Condition: Actinic Keratosis; Squamous Cell Carcinoma
MeSH terms: Carcinoma; Carcinoma, Squamous Cell; Keratosis, Actinic; Keratosis
Study type: Interventional

Summary: 
      The purpose of this study is to correlate pathological features from specimens in order to
      determine if this new molecular diagnostic technique can be used to detect risk of skin
      cancer.
    

Detailed description: 
      Squamous cell carcinoma is the culmination of a multistep carcinogenesis process that is
      preceded by early stages referred as squamous dysplasia and actinic keratosis. Squamous
      dysplasia (SD) also known as "field effect" is clinically characterized by xerosis (dry,
      scaly skin), lentigines and uneven pigmentation. While morphologically skin biopsies and
      cytology samples show only minimal changes, at the molecular level it is known that SD is
      characterized by small clone keratinocytes carrying mutations of the P53 gene. An optical
      technology called Partial Wave Spectroscopy (PWS) probes nanoscale structures in the order of
      tens to a few hundred nanometers. PWS is a light back-scattering techniques that uses light
      reflected off of a tissue sample. The measured biomarker is sensitive to the cytosolic and
      nucleic architecture within the cell and quantifies the nanoscale disorder, which
      conventional light microscopy fails to appreciate. PWS has allowed to identify various grades
      of structural disorder at the nanoscale level of colonic and pulmonary premalignant cell
      samples. Using PWS we aim to study the spectrum of cutaneous SD from patients at high risk
      for SCC development. Since squamous dysplasia is difficult to assess with routine histology
      and cytopathology and a grading system for squamous dysplasia by routine histology or
      cytology is not available, we propose to assess the value of PWS as a new and more sensitive
      imaging technique. By identifying the degree of SD at the molecular level, we may be able to
      intervene with close surveillance, early treatment and chemoprevention strategies to achieve
      lower morbidity by means of fewer and smaller skin cancers.
    

Intervention name(s): Superficial shave biopsy
Intervention type(s): Procedure
Intervention description(s): Sample will be obtained from random dorsal forearm skin sites without evidence of keratotic lesions. The site will be selected by the investigator. Skin will first be wiped with an alcohol pad and 1% lidocaine will be superficially infiltrated per standard skin surgical procedures. 30% trichloroacetic acid (TCA, standard chemical peel) will then be applied for five minutes. TCA will be neutralized using bicarbonate. Using a cytology brush (a small brush which is used to collect cells during the course of a biopsy) cells will be collected by gentle scraping surface of the skin. Then, a superficial shave biopsy specimen, obtained by using a dermablade (a flexible, one piece blade specifically designed for shave biopsy and excision of skin lesions) will be obtained.
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Health Services Research
Keywords: Non melanoma skin cancer; Field of cancerization; Skin carcinogenesis