Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

43 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-09-30

Study Completion Date

2010-04-30

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Nevi

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Nevi from participants

Benign nevi dermoscopically sub-classified into 4 dermoscopic types (i.e., with globular, reticular, mixed pattern with globules in the center and mixed pattern with globules at the periphery) were excised from healthy volunteers for further genetical analysis

Group Type EXPERIMENTAL

To test the frequency of BRAF and NRAS mutations among nevi

Intervention Type GENETIC

Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations

Interventions

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To test the frequency of BRAF and NRAS mutations among nevi

Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations

Intervention Type GENETIC

Other Intervention Names

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NM_004333; Homo sapiens v-raf murine sarcoma viral oncogene homolog B1

Eligibility Criteria

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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

Minimum Eligible Age

9 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes