Use of Fiber-optic Probe for Non-invasive Diagnosis of Melanoma and Assessment of Impact of Ultraviolet (UV) Exposure on Skin

University of Pittsburgh16 enrolled

Overview

This study is designed to collect information about melanoma using a research probe, a device placed only on the skin. This study will investigate whether using the probe to examine skin lesions could improve the accuracy of identification pre-cancerous melanoma lesions or to predict the risk melanoma in the skin of subjects. Ultimately, we would see this technique used routinely as a non-invasive device during subjects' skin examination to aid dermatologists to identify pre-cancerous (melanoma) lesions without taking tissue samples of the skin. Alternatively, this technique would, in the future, also be used to screen patients at risk for melanoma.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Melanoma

Eligibility

Sex: ALLMin age: 19 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Male and female above 18 years of age; * Subjects who are planned to undergo skin examinations with and without atypical nevi, with and without personal or family history of melanoma and potentially with pigmented lesions to be removed for medical care or cosmetic purposes. Exclusion Criteria: * Individuals whose pathology cannot be obtained or retrieved. * Inability to provide informed consent.

Locations (3)

Outcomes

Primary Outcomes

Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia

To correct for skin color effect and heterogeneity, the readings of the pigmented lesion will be normalized by the readings taken from the corresponding normal skin around the lesion.

Time frame: 3 years

Secondary Outcomes

To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;

Time frame: 3 years

To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure

Time frame: 3 years

To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions

Time frame: 3 years