Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
OHSU Knight Cancer Institute
ClinicalTrials.gov Identifier:
NCT01556503
First received: March 12, 2012
Last updated: April 21, 2016
Last verified: April 2016
  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:


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



Enrollment: 24
Study Start Date: April 2011
Study Completion Date: November 2013
Primary Completion Date: November 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   (Child, Adult, Senior)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

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: April 21, 2016
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 September 23, 2016