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

M

Medical University of Graz

Status

Completed

Conditions

Nevi

Treatments

Genetic: To test the frequency of BRAF and NRAS mutations among nevi

Study type

Interventional

Funder types

Other

Identifiers

NCT00422448
V9-B05 (FWF)

Details and patient eligibility

About

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.

Full 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

Enrollment

43 patients

Sex

All

Ages

9 to 80 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Basic Science

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

43 participants in 1 patient group

Nevi from participants
Experimental group
Description:
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
Treatment:
Genetic: To test the frequency of BRAF and NRAS mutations among nevi

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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