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

This study is not yet open for participant recruitment.
Verified September 2010 by Sheba Medical Center
Sponsor:
Information provided by:
Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01194947
First received: September 2, 2010
Last updated: NA
Last verified: September 2010
History: No changes posted
  Purpose

Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.


Condition Intervention
Common Melanocytic Nevi
 Device: RCM imaging

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective

Resource links provided by NLM:

MedlinePlus related topics: Birthmarks Moles
U.S. FDA Resources

Further study details as provided by Sheba Medical Center:

Primary Outcome Measures:
  • Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images). [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Description of rates of retention and change in RCM pattern of nevi during follow-up [ Time Frame: 3 YEARS ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2010
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

patients visiting the pigmented lesion clinic for skin cancer surveillance

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01194947

Contacts
Contact: ALON SCOPE, MD 972-3-5302443 scopea1@gmail.com

Locations
Israel
Sheba Medical Center Not yet recruiting
Rmat-gan, Israel, 52621
Contact: ALON SCOPE, MD     972-3-5302443        
Principal Investigator: ALON SCOPE, MD            
Sponsors and Collaborators
Sheba Medical Center
Investigators
Principal Investigator: ALON SCOPE, MD Sheba Medical Center
  More Information

No publications provided

Responsible Party: DR. ALONE SCOPE, SHEBA MEDICAL CENTER
ClinicalTrials.gov Identifier: NCT01194947     History of Changes
Other Study ID Numbers: SHEBA-10-8015-AS-CTIL
Study First Received: September 2, 2010
Last Updated: September 2, 2010
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

Keywords provided by Sheba Medical Center:
banal-appearing nevi
NEVUS

Additional relevant MeSH terms:
Nevus
Nevus, Pigmented
Nevus, Epithelioid and Spindle Cell
Nevi and Melanomas
 Neoplasms by Histologic Type
Neoplasms
Nevus, Spindle Cell

ClinicalTrials.gov processed this record on May 16, 2013