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

Sponsor

University of Pittsburgh (Other)

Overall Status

Terminated

CT.gov ID

NCT01085396

Collaborator

(none)

Enrollment

Locations

Duration (Months)

5.3

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Melanoma

Study Design

Study Type:

Observational

Actual Enrollment :

16 participants

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Mar 1, 2010

Actual Primary Completion Date :

Oct 1, 2014

Actual Study Completion Date :

Oct 1, 2014

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

19 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC Presbyterian Dept. of Dermatology	Pittsburgh	Pennsylvania	United States	15213
2	UPCI - Hillman Cancer Center	Pittsburgh	Pennsylvania	United States	15232
3	UPMC Shadyside Place - Dermatology Unit	Pittsburgh	Pennsylvania	United States	15232

Sponsors and Collaborators

University of Pittsburgh

Investigators

Principal Investigator: Yang Liu, PhD, University of Pittsburgh

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yang Liu, PhD, Principal Investigator, University of Pittsburgh

ClinicalTrials.gov Identifier:

NCT01085396

Other Study ID Numbers:

UPCI 09-077

First Posted:

Mar 11, 2010

Last Update Posted:

May 27, 2015

Last Verified:

May 1, 2014

Keywords provided by Yang Liu, PhD, Principal Investigator, University of Pittsburgh

Fiber Optic

Melanoma

UV Exposure

Additional relevant MeSH terms:

Melanoma

Study Results

No Results Posted as of May 27, 2015