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Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis

This study is currently recruiting participants.
Verified January 2013 by OHSU Knight Cancer Institute
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01556503
First received: March 12, 2012
Last updated: January 7, 2013
Last verified: January 2013
History of Changes
  Purpose

The purpose of this study is to show how well a new device, confocal microscope, works to detect malignant melanoma, a type of skin cancer.


Condition Intervention
Melanoma
 Device: VivaScope System

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis

Resource links provided by NLM:

MedlinePlus related topics: Cancer Melanoma
U.S. FDA Resources

Further study details as provided by OHSU Knight Cancer Institute:

Primary Outcome Measures:
  • Sensitivity of confocal microscope to improve melanoma detection [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.

  • Specificity of the confocal microscope to improve melanoma detection [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis


Secondary Outcome Measures:
  • Patterns seen on the confocal image [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]

    Evaluate and confirm patterns seen on the confocal image, which are characteristic of melanoma and atypical nevi:

    A) Pagetoid melanoma cells: melanocytes in suprabasal areas of the epidermis B) Irregular dermal-epidermal junction



Estimated Enrollment: 200
Study Start Date: April 2011
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Pigmented Lesion
Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.
 Device: VivaScope System
VivaScope System, Model#s 1500 and 2500
Other Name: Confocal Microscope

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Primary care clinic

Criteria

Inclusion Criteria:

  • Age 12 or older
  • Patient who has already been selected by their dermatologist for biopsy of a suspicious pigmented lesion and who consents to participate in the study
  • Signed informed consent

Exclusion Criteria:

  • Age < 12 years
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01556503

Locations
United States, Oregon
OHSU Knight Cancer Institute Recruiting
Portland, Oregon, United States, 97239
Contact: Eric Simpson         simpsone@ohsu.edu    
Principal Investigator: Eric Simpson            
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Eric Simpson OHSU Knight Cancer Institute
  More Information

No publications provided

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01556503     History of Changes
Other Study ID Numbers: IRB00006939, CPC-11033-L
Study First Received: March 12, 2012
Last Updated: January 7, 2013
Health Authority: United States: Food and Drug Administration

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 May 21, 2013