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Completed

NCT Number: NCT01905891

Nanocytology Test to Evaluate Skin Cancer in High Risk Patients

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.

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Key information

Conditions

Actinic Keratosis Carcinoma Carcinoma, Squamous Cell Keratosis Keratosis, Actinic Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Neoplasms, Squamous Cell Precancerous Conditions Skin Diseases Skin and Connective Tissue Diseases Squamous Cell Carcinoma

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18 to 89 years old, male and female, Fitzpatrick skin phototype I - III
  • Photodamage skin grades 3 - 4 (global assessment)
  • Medical history of precancerous lesions and or known history of SCC or healthy volunteers

Exclusion criteria

  • Subjects under 18 years old
  • Pregnant women or lactating mothers
  • Treatment with systemic chemotherapy within 4 weeks period before consent
  • Known HIV+ patients (self-reported)

Treatment and study plan

Superficial shave biopsy

Procedure

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.

Primary outcomes

  1. Nanocytology assessment of skin cancer risk

    Time frame: 1 year

    The primary outcome measure is to correlate clinical phenotype (age, skin phototype, level of photodamage, history of prior skin cancers) with morphology and nuclear characteristics, in order to determine if this new molecular diagnostic technique can be used to detect early stages of skin carcinogenesis and identify high risk-patients.

Secondary outcomes

  1. Compare nanocytology assessment with pathological findings

    Time frame: 1 year

    Secondary outcome measure is to compare PWS results and clinical phenotype with the evaluation of skin samples by routine cytology/pathology, as they relate to the clinical level of overall photodamaged and prior history of skin cancers.

Sponsors and collaborators

Lead sponsor

Northwestern University

Other

Registry information

Official study title

Nanocytology Evaluation of Epidermal Cells to Assess Risk of Squamous Cell Carcinoma and Field Cancerization in High Risk Patients

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 23, 2013
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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