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

NCT01085396 | Terminated DMC

• 1 other identifier: UPCI 09-077
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 3

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.

Conditions

Melanoma

Keywords

Fiber Optic; Melanoma; UV Exposure

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• 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

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

1. normal volunteers 2. patients without personal and family history of melanoma 3. patients with personal or family history of melanoma who are followed in the UPCI Melanoma Program with either atypical nevi or without atypical nevi.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Pittsburgh: lead

Study Sites (3)

UPMC Presbyterian Dept. of Dermatology

Pittsburgh, Pennsylvania, 15213, United States

Location

UPCI - Hillman Cancer Center

Pittsburgh, Pennsylvania, 15232, United States

Location

UPMC Shadyside Place - Dermatology Unit

Pittsburgh, Pennsylvania, 15232, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

A pigmented lesion is removed as part of the subjects routine care when it is felt to be suspicious for severe atypica or early malignancy, and sometimes because the patient desires removal of lesions for cosmetic reasons, or because the lesion is irritated or located in a zone of traum. For this research study, samples of the tumor tissue from these clinical care biopsies will be studied. Researchers will look at markers and search for additional characteristics that may help them better understand Melanoma. This will be optional to subjects. If subjects do not agree to have their tissue kept for future research purposes they can still participate in the rest of this study.

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine Tumors; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Nerve Tissue; Nevi and Melanomas; Skin Neoplasms; Neoplasms by Site; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Yang Liu, PhD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 10, 2010
• First Posted: March 11, 2010
• Study Start: March 1, 2010
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2014
• Last Updated: May 27, 2015

Record last verified: 2014-05

Locations

US (3)