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

Terminated

• Conditions: Melanoma

• Registration Number: NCT01085396
• Lead Sponsor: University of Pittsburgh

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-03
• Study First Submitted: 2010-03-10
• Study First Submitted QC: 2010-03-10
• Study First Posted: 2010-03-11
• Status Verified: 2014-05
• Primary Completion: 2014-10
• Study Completion: 2014-10
• Last Update Submitted: 2015-05-26
• Last Update Posted: 2015-05-27

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 16

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.

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Exclusion Criteria

• Individuals whose pathology cannot be obtained or retrieved.
• Inability to provide informed consent.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia	3 years	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.

Secondary Outcome Measures

Name	Time	Method
To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;	3 years
To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure	3 years
To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions	3 years

Trial Locations

Locations (3)

UPMC Presbyterian Dept. of Dermatology; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPCI - Hillman Cancer Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

UPMC Shadyside Place - Dermatology Unit; 🇺🇸 Pittsburgh, Pennsylvania, United States