Trials Sponsors Conditions Drugs Pricing

Conditions

Actinic Keratosis Squamous Cell Carcinoma

Keywords

Non melanoma skin cancerField of cancerizationSkin 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 biopsyProcedure

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 cancerSubjects with healthy skin

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years - 89 Years

Sexall

Healthy VolunteersYes

Age GroupsAdult (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)

Sponsors & Collaborators

Northwestern University
Otherlead

Study Sites (1)

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

MeSH Terms

Conditions

Keratosis, ActinicCarcinoma, Squamous Cell

Condition Hierarchy (Ancestors)

Precancerous ConditionsNeoplasmsKeratosisSkin DiseasesSkin and Connective Tissue DiseasesCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasms, Squamous Cell

Study Officials

Joan Guitart, MD
Northwestern University
PRINCIPAL INVESTIGATOR

Enrollment

7 participants (actual enrollment reported by the registry).

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 2013

Date type not reported

This date has not been verified as actual or estimated.

Nanocytology Test to Evaluate Skin Cancer in High Risk Patients

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Subjects at risk of skin cancer

Subjects with healthy skin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

Study Start

First Submitted

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Subjects at risk of skin cancer

Subjects with healthy skin

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations