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

This study is not yet open for participant recruitment.
Verified March 2010 by University of Pittsburgh
Sponsor:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01085396
First received: March 10, 2010
Last updated: NA
Last verified: March 2010
History: No changes posted
  Purpose

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
Melanoma

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Optical Spectroscopy for Non-invasive Diagnosis of Melanoma and Assessment of Impact of UV Exposure on Skin

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • Investigate the ability of the fiber-optic probe to identify lesions of melanoma and severe/high-grade dysplasia [ Time Frame: 3 years ] [ Designated as safety issue: No ]
    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; [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To test whether the fiber-optic probe readings are different among tissues with different degree of sun exposure [ Time Frame: 3 years ] [ Designated as safety issue: No ]
  • To test whether the fiber-optic probe readings are different between the most and the least suspicious lesions [ Time Frame: 3 years ] [ Designated as safety issue: No ]

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.


Estimated Enrollment: 400
Study Start Date: May 2010
Estimated Study Completion Date: May 2014
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01085396

Contacts
Contact: Yang Liu, PhD 412-623-0036 liuy@pitt.edu

Locations
United States, Pennsylvania
UPCI - Hillman Cancer Center Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Principal Investigator: Yang Liu, PhD            
Sub-Investigator: John Kirkwood, MD            
Sub-Investigator: Laura Ferris, MD            
Sub-Investigator: Howard Edington, MD            
Sub-Investigator: Larisa Geskin, MD            
Sub-Investigator: Drazen Jucik, MD            
Sub-Investigator: Hussein Tawbi, MD            
Sub-Investigator: Hassane Zarour, MD            
Sub-Investigator: Uma Rao, MD            
Sub-Investigator: Ahmad Tarhini, MD            
Sub-Investigator: Stergios Moschos, MD            
Sub-Investigator: Lisa Grandinetti, MD            
UPMC Presbyterian Dept. of Dermatology Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15213
UPMC Shadyside Place - Dermatology Unit Not yet recruiting
Pittsburgh, Pennsylvania, United States, 15232
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Yang Liu, PhD University of Pittsburgh
  More Information

No publications provided

Responsible Party: Yang Liu, PhD, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01085396     History of Changes
Other Study ID Numbers: UPCI 09-077
Study First Received: March 10, 2010
Last Updated: March 10, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
Fiber Optic
Melanoma
UV Exposure

Additional relevant MeSH terms:
Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
 Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas

ClinicalTrials.gov processed this record on June 18, 2013