Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy

September 2, 2010 updated by: Sheba Medical Center
Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Israel
      • Rmat-gan, Israel, 52621
        • Sheba Medical Center
        • Contact:
          • ALON SCOPE, MD
          • Phone Number: 972-3-5302443
        • Principal Investigator:
          • ALON SCOPE, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

patients visiting the pigmented lesion clinic for skin cancer surveillance

Description

Inclusion Criteria:

  • Patients visiting the Sheba Medical Center pigmented lesion clinic for skin examination
  • Patients having at least three banal-appearing nevi, one on the upper back, one on the lower back and one on the lower extremity (excluding foot), which are amenable for RCM examination.

Exclusion Criteria:

  • Patients who are unwilling or medically unable to lie down for 30 minutes.
  • Pregnant women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Study participants
patients 18 or older presenting to the Sheba Medical Center pigmented lesion clinic for skin cancer surveillance. Patients routinely undergo total skin examination that includes clinical and dermoscopic evaluation of skin lesions. Patients also routinely undergo annual total body digital photography that allows identification of new or changing lesions.
Device: RCM imaging
RCM imaging will be performed using a commercially-available RCM (Vivascope 1500, Lucid Inc, Rochester, NY, USA) with 830-nm diode laser with emitting power less than 35 milliwatts

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).
Time Frame: 3 YEARS
3 YEARS

Secondary Outcome Measures

Outcome Measure
Time Frame
Description of rates of retention and change in RCM pattern of nevi during follow-up
Time Frame: 3 YEARS
3 YEARS

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Investigators

  • Principal Investigator: ALON SCOPE, MD, Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (ANTICIPATED)

September 1, 2013

Study Completion (ANTICIPATED)

September 1, 2013

Study Registration Dates

First Submitted

September 2, 2010

First Submitted That Met QC Criteria

September 2, 2010

First Posted (ESTIMATE)

September 3, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

September 3, 2010

Last Update Submitted That Met QC Criteria

September 2, 2010

Last Verified

September 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHEBA-10-8015-AS-CTIL

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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