Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques

July 23, 2019 updated by: University of Florida
The purpose of this research study is to determine if a very sensitive chemistry lab analyzer can be used to smell a skin cancer (like melanoma) similar to some dogs.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Types of skin cancer, like melanoma, are likely to spread and are becoming increasingly common. At this time, healthcare providers look at patient's skin and remove a sample of suspicious areas of the skin (biopsy) to test for cancer.

This research study will inspect cotton and cloth swabs of normal skin and suspicious areas of the skin that are going to be biopsied just before the biopsy. The swabs will be looked at with a very sensitive chemistry lab analyzer to see if the lab analyzer can confirm conventional lab test findings.

Study Type

Observational

Enrollment (Actual)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Florida
      • Gainesville, Florida, United States, 32610-3003
        • UF Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin

Description

Inclusion Criteria:

  • 18 years of age or older
  • Seen at the dermatology clinic & determined to need a skin biopsy of a suspicious lesion

Exclusion Criteria:

  • < 18 years of age

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dermatology patients
Patients seen in the dermatology clinic with suspicious skin lesion to be biopsied will have 4 skin swabs, 2 of the skin lesion and 2 of an area of unafflicted skin.
Other: Dermatology patients
Cleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline.
Other: Dermatology patients
Cleanse a suspicious lesion (potential melanoma) with a saline cotton swab.
Other: Dermatology patients
This intervention follows the standard of care for patients with a suspicious skin lesion (potential melanoma) the physician plans to biopsy. The alcohol swab used to prep the site will be stored for testing rather than discarded.
Other: Dermatology patients
Cleanse an area of unafflicted (control) skin with an alcohol swab.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Compare the off line spectral analyses of saline and alcohol skin swabs of normal control, melanoma negative and melanoma positive skin biopsies.
Time Frame: 1 day
Determine if the melanomas have unique identifying spectra that might be applied to noninvasive melanoma skin cancer screening in lieu of taking a biopsy
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Florida

Investigators

  • Principal Investigator: Nikolaus Gravenstein, MD, The Jerome H. Modell, MD, Professor of Anesthesiology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2015

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

October 3, 2017

Study Registration Dates

First Submitted

March 9, 2015

First Submitted That Met QC Criteria

March 13, 2015

First Posted (Estimate)

March 19, 2015

Study Record Updates

Last Update Posted (Actual)

July 24, 2019

Last Update Submitted That Met QC Criteria

July 23, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB201400739

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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