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Clinical Trials/NCT01085396
NCT01085396
Terminated
Not Applicable

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

University of Pittsburgh3 sites in 1 country16 target enrollmentMarch 2010
ConditionsMelanoma

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Melanoma
Sponsor
University of Pittsburgh
Enrollment
16
Locations
3
Primary Endpoint
Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia
Status
Terminated
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
March 2010
End Date
October 2014
Last Updated
10 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yang Liu, PhD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

Time Frame: 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 Outcomes

  • 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)

Study Sites (3)

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