Analysis of Skin Lesions for Melanoma Presence by Volatile Spectroscopy Techniques

NCT ID: NCT02393001

Last Updated: 2019-07-24

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

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-05-31

Study Completion Date

2017-10-03

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Melanoma

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

Dermatology patients

Intervention Type OTHER

Cleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline.

Dermatology patients

Intervention Type OTHER

Cleanse a suspicious lesion (potential melanoma) with a saline cotton swab.

Dermatology patients

Intervention Type OTHER

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

Intervention Type OTHER

Cleanse an area of unafflicted (control) skin with an alcohol swab.

Interventions

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Dermatology patients

Cleanse an area of unafflicted (control) skin with a cotton 2 x 2 dampened with saline.

Intervention Type OTHER

Dermatology patients

Cleanse a suspicious lesion (potential melanoma) with a saline cotton swab.

Intervention Type 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.

Intervention Type OTHER

Dermatology patients

Cleanse an area of unafflicted (control) skin with an alcohol swab.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nikolaus Gravenstein, MD

Role: PRINCIPAL_INVESTIGATOR

The Jerome H. Modell, MD, Professor of Anesthesiology

Locations

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UF Health

Gainesville, Florida, United States

Site Status

Countries

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United States

Other Identifiers

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IRB201400739

Identifier Type: -

Identifier Source: org_study_id

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