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


N/A
12 Years
N/A
Open (Enrolling)
Both
Melanoma

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Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Cross-Sectional

Outcome Measure:

Sensitivity of confocal microscope to improve melanoma detection

Outcome Description:

Determine the sensitivity of confocal microscopy in the diagnosis of melanoma by comparison to the gold standard histopathologic diagnosis.

Outcome Time Frame:

Up to 1 year

Safety Issue:

No

Principal Investigator

Eric Simpson

Investigator Role:

Principal Investigator

Investigator Affiliation:

OHSU Knight Cancer Institute

Authority:

United States: Food and Drug Administration

Study ID:

IRB00006939

NCT ID:

NCT01556503

Start Date:

April 2011

Completion Date:

Related Keywords:

  • Melanoma
  • Melanoma

Name

Location

OHSU Knight Cancer InstitutePortland, Oregon  97239