Clinical trial NCT00422448: Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.
Official title: BRAF and Nevi.Nevi Are Common Benign Pigmented Tumors of the Skin. Mutations in So-called BRAF and NRAS Genes Genes Appear to be Initiating Events Responsible for the Formation of Nevi.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Nevi
Keywords: Dermoscopy
Histopathology
Genetics
Nevi
Nevogenesis
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2007-01-17
Enrollment: 43
Sex: ALL
Minimum age (years): 9
Maximum age (years): 80
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: This project is a multicenter study in which we will investigate a dual concept of nevogenesis. Study location is the Department of Dermatology at the Medical University of Graz in collaboration with centers in Austria (Vienna), Italy (Naples, Benevento, Modena), Spain (Barcelona) and the United States (New York).

The hypothesis is that small congenital melanocytic nevi (CMN), "early" acquired melanocytic nevi in childhood (AMN) and dermal nevi, all dermatoscopically characterized by globular pattern, belong to the same spectrum of genetically determined melanocytic proliferations that develop due to endogenous pathways, in contrast to "true" acquired melanocytic nevi, dermatoscopically showing reticular pattern, that develop due to exogeneous factors such as UV-exposure.

Detailed description: The investigations to this study will verify whether small CMN, "early" AMN and dermal nevi, characterized by globular pattern differ in their genetic alterations compared to reticular typed nevi. It will be expected that globular typed nevi and eventually dermal nevi lack B-RAF mutations whereas reticular nevi show alterations in the B-RAF gene. Study location: Graz

Eligibility criteria: Inclusion Criteria:

* Healthy individuals aged 9 to 80 years showing one or more dermoscopically benign nevi with either uniform globular-cobblestone pattern or reticular pattern or a combination of both types

Exclusion Criteria:

* Children under the age of 9 years
* Pregnant woman
* Patients with atypical nevi (i.e., melanoma cannot be clinically ruled out)
* Patients with immunosuppression
* Patients with sun exposure 4 weeks before enrollment

Primary outcomes:
measure: Frequency of BRAF Mutations Among Nevi
timeFrame: up to 30 months
Secondary outcomes:
measure: Frequency of NRAS Mutations Among Nevi
timeFrame: 30 months
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Department of Dermatology, Medical University of Graz
Study officials:
affiliation: Department of Dermatology, Medical University of Graz
name: Iris Zalaudek, MD
role: STUDY_CHAIR
References:
citation: Zalaudek I, Grinschgl S, Argenziano G, Marghoob AA, Blum A, Richtig E, Wolf IH, Fink-Puches R, Kerl H, Soyer HP, Hofmann-Wellenhof R. Age-related prevalence of dermoscopy patterns in acquired melanocytic naevi. Br J Dermatol. 2006 Feb;154(2):299-304. doi: 10.1111/j.1365-2133.2005.06973.x.
citation: Zalaudek I, Hofmann-Wellenhof R, Soyer HP, Ferrara G, Argenziano G. Naevogenesis: new thoughts based on dermoscopy. Br J Dermatol. 2006 Apr;154(4):793-4. doi: 10.1111/j.1365-2133.2006.07152.x. No abstract available.
citation: Pellacani G, Scope A, Ferrari B, Pupelli G, Bassoli S, Longo C, Cesinaro AM, Argenziano G, Hofmann-Wellenhof R, Malvehy J, Marghoob AA, Puig S, Seidenari S, Soyer HP, Zalaudek I. New insights into nevogenesis: in vivo characterization and follow-up of melanocytic nevi by reflectance confocal microscopy. J Am Acad Dermatol. 2009 Dec;61(6):1001-13. doi: 10.1016/j.jaad.2009.04.018. Epub 2009 Oct 14.