Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques

Melanoma Clinical Trial

Official title:

Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02393001
• Other study ID #: IRB201400739
• Status: Completed
• Start date: May 2015
• Est. completion date: October 3, 2017

Study information

• Verified date: July 2019
• Source: University of Florida
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: October 3, 2017
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanoma

Intervention

Other:
• Dermatology patients
Cleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline.
• Dermatology patients
Cleanse a suspicious lesion (potential melanoma) with a saline cotton swab.
• 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.
• Dermatology patients
Cleanse an area of unafflicted (control) skin with an alcohol swab.

Locations

Country	Name	City	State
United States	UF Health	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Compare the off line spectral analyses of saline and alcohol skin swabs of normal control, melanoma negative and melanoma positive skin biopsies.	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