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

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

Status

Terminated

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01085396

Enrollment

Registered

2010-03-11

Start date

2010-03-31

Completion date

2014-10-31

Last updated

2015-05-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Melanoma

Keywords

Fiber Optic, Melanoma, UV Exposure

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.

Interventions

None listed

Study design

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

19 Years to No maximum

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame
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

Countries

United States

Outcome results