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

Melanoma Clinical Trial

Official title:

Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01085396
• Other study ID #: UPCI 09-077
• Status: Terminated
• Phase: N/A
• First received: March 10, 2010
• Last updated: May 26, 2015
• Start date: March 2010
• Est. completion date: October 2014

Study information

• Verified date: May 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 16
• Est. completion date: October 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 19 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	UPCI - Hillman Cancer Center	Pittsburgh	Pennsylvania
United States	UPMC Presbyterian Dept. of Dermatology	Pittsburgh	Pennsylvania
United States	UPMC Shadyside Place - Dermatology Unit	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 years	No
Secondary	To test whether the fiber-optic probe can discriminate the severe/high-grade dysplasia from the mild and moderate dysplastic nevi;		3 years	No
Secondary	To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure		3 years	No
Secondary	To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions		3 years	No