Nanocytology Test to Evaluate Skin Cancer in High Risk Patients

NCT01905891 | Completed DMC

• 1 other identifier: JG05012013
• Study Type: interventional
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Actinic Keratosis; Squamous Cell Carcinoma

Keywords

Non melanoma skin cancer; Field of cancerization; Skin carcinogenesis

Outcome Measures

Primary Outcomes (1)

• Nanocytology assessment of skin cancer risk

  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.

  1 year

Secondary Outcomes (1)

• Compare nanocytology assessment with pathological findings

  1 year

Study Arms (2)

Subjects at risk of skin cancer

OTHER

Subjects at risk of skin cancer (sun-damaged skin) a superficial shave biopsy will be performed.

Procedure: Superficial shave biopsy

Subjects with healthy skin

OTHER

Subjects without sun-damaged skin a superficial shave biopsy will be performed.

Procedure: Superficial shave biopsy

Interventions

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.

Subjects at risk of skin cancer; Subjects with healthy skin

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Keratosis, Actinic; Carcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

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

Study Officials

• Joan Guitart, MD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: July 18, 2013
• First Posted: July 23, 2013
• Study Start: July 1, 2013
• Primary Completion: November 1, 2014
• Study Completion: November 1, 2014
• Last Updated: November 19, 2014

Record last verified: 2014-11

Locations

US (1)