NCT01556503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
24

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Apr 2011

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2011

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

March 12, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 16, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

April 25, 2016

Status Verified

April 1, 2016

Enrollment Period

2.6 years

First QC Date

March 12, 2012

Last Update Submit

April 21, 2016

Conditions

Melanoma

Outcome Measures

Primary Outcomes (2)

  • Sensitivity of confocal microscope to improve melanoma detection

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

    Up to 1 year

  • Specificity of the confocal microscope to improve melanoma detection

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

    Up to 1 year

Secondary Outcomes (1)

  • Patterns seen on the confocal image

    Up to 1 year

Study Arms (1)

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

Interventions

VivaScope SystemDEVICE

VivaScope System, Model#s 1500 and 2500

Also known as: Confocal Microscope
Pigmented Lesion

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Primary care clinic

You may qualify if:

  • 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

You may not qualify if:

  • Age \< 12 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

OHSU Knight Cancer Institute

Portland, Oregon, 97239, United States

Location

MeSH Terms

Conditions

Melanoma

Condition Hierarchy (Ancestors)

Neuroendocrine TumorsNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Nerve TissueNevi and MelanomasSkin NeoplasmsNeoplasms by SiteSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Eric Simpson

    OHSU Knight Cancer Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2012

First Posted

March 16, 2012

Study Start

April 1, 2011

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

April 25, 2016

Record last verified: 2016-04

Locations

US(1)