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Status unknownNCT01194947Updated Sep 3, 2010

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

An observational study in Common Melanocytic Nevi, sponsored by Sheba Medical Center. Status unknown at 1 site in Israel. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-09-03.

Sponsored by Sheba Medical Center · Observational

The sponsor has not verified this record recently (last verified Sep 2010), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
90
Ages
18 Years and older
Sex
All
01

Study summary

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

02

Conditions studied

  • Common Melanocytic Nevi

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Keywords

  • banal-appearing nevi
  • NEVUS
03

In context

Nevus

47 studies on the registry are indexed under Nevus; 9 are open to participants now.

This study's planned enrollment of 90 is below the median of 145 across 28 observational studies indexed under Nevus.

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Lead sponsor

Sheba Medical Center is the lead sponsor of 678 studies on the registry; 63 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients visiting the pigmented lesion clinic for skin cancer surveillance

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients who are unwilling or medically unable to lie down for 30 minutes.
  • Pregnant women
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
90 participants (estimated)

Groups and cohorts

  • 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

Interventions

  • DeviceRCM 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

06

What researchers measure

Primary outcomes

  1. Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images).

    Time frame: 3 YEARS

Secondary outcomes

  1. Description of rates of retention and change in RCM pattern of nevi during follow-up

    Time frame: 3 YEARS

07

Study locations

1 site
  • Sheba Medical Center
    Rmat-gan, 52621, Israel
    • ALON SCOPE, MD · Contact972-3-5302443
    • ALON SCOPE, MD · Principal investigator
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 3, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01194947
First posted
Sep 3, 2010
Start date
Sep 2010
Primary completion
Sep 2013 (estimated)
Completion
Sep 2013 (estimated)
Last update
Sep 3, 2010

Study contacts

ALON SCOPE, MD
Contact
scopea1@gmail.com
972-3-5302443
ALON SCOPE, MD
principal investigator · Sheba Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2010. You cannot join it, but the record below documents what was studied.

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