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

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ClinicalTrials.gov Identifier: NCT01556503
Recruitment Status : Completed
First Posted : March 16, 2012
Last Update Posted : April 25, 2016
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute

Brief Summary:
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 or disease Intervention/treatment
Melanoma Device: VivaScope System

Study Type : Observational
Actual Enrollment : 24 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Sensitivity/Specificity Study of Non-invasive Imaging for Melanoma Diagnosis
Study Start Date : April 2011
Actual Primary Completion Date : November 2013
Actual Study Completion Date : November 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Melanoma

Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. Sensitivity of confocal microscope to improve melanoma detection [ Time Frame: Up to 1 year ]
    Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.

  2. Specificity of the confocal microscope to improve melanoma detection [ Time Frame: Up to 1 year ]
    Determine the specificity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis


Secondary Outcome Measures :
  1. Patterns seen on the confocal image [ Time Frame: Up to 1 year ]

    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




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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01556503


Locations
United States, Oregon
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97239
Sponsors and Collaborators
OHSU Knight Cancer Institute
Investigators
Principal Investigator: Eric Simpson OHSU Knight Cancer Institute

Responsible Party: OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier: NCT01556503     History of Changes
Other Study ID Numbers: IRB00006939
CPC-11033-L ( Other Identifier: OHSU Knight Cancer Institute )
First Posted: March 16, 2012    Key Record Dates
Last Update Posted: April 25, 2016
Last Verified: April 2016

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