Classification and Longitudinal Follow-up of Common Melanocytic Nevi With in Vivo Reflectance Confocal Microscopy
- Conditions
- Common Melanocytic Nevi
- Interventions
- Device: RCM imaging
- Registration Number
- NCT01194947
- Lead Sponsor
- Sheba Medical Center
- Brief Summary
Our working hypothesis is that reflectance confocal microscopy (RCM) can identify distinct subsets of melanocytic nevi that retain their distinctive pattern over time.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 90
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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Study participants RCM imaging 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.
- Primary Outcome Measures
Name Time Method Inter-rater agreement on assignment of nevi to RCM patterns (baseline and follow-up images). 3 YEARS
- Secondary Outcome Measures
Name Time Method Description of rates of retention and change in RCM pattern of nevi during follow-up 3 YEARS
Trial Locations
- Locations (1)
Sheba Medical Center
🇮🇱Rmat-gan, Israel