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

NCT ID: NCT01556503

Last Updated: 2016-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

24 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-04-30

Study Completion Date

2013-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Melanoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Pigmented Lesion

Patients identified as having a concerning pigmented lesion and the physician believes it is appropriate to biopsy to rule out melanoma.

VivaScope System

Intervention Type DEVICE

VivaScope System, Model#s 1500 and 2500

Interventions

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VivaScope System

VivaScope System, Model#s 1500 and 2500

Intervention Type DEVICE

Other Intervention Names

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Confocal Microscope

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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OHSU Knight Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Eric Simpson

Role: PRINCIPAL_INVESTIGATOR

OHSU Knight Cancer Institute

Locations

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OHSU Knight Cancer Institute

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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CPC-11033-L

Identifier Type: OTHER

Identifier Source: secondary_id

IRB00006939

Identifier Type: -

Identifier Source: org_study_id

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