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Nanocytology Test to Evaluate Skin Cancer in High Risk Patients

NCT ID: NCT01905891

Last Updated: 2014-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-11-30

Brief Summary

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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

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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.

Conditions

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Actinic Keratosis Squamous Cell Carcinoma

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Subjects at risk of skin cancer

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

Group Type OTHER

Superficial shave biopsy

Intervention Type 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 with healthy skin

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

Group Type OTHER

Superficial shave biopsy

Intervention Type 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.

Interventions

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Superficial shave biopsy

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Northwestern University

OTHER

Sponsor Role lead

Responsible Party

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Joan Guitart

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Joan Guitart, MD

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

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Northwestern Memorial Hospital

Chicago, Illinois, United States

Site Status

Countries

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United States

Other Identifiers

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JG05012013

Identifier Type: -

Identifier Source: org_study_id