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OpenTrials
Completed

NCT Number: NCT00422448

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

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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Key information

Conditions

Nevi Neoplasms Neoplasms by Histologic Type Nevi and Melanomas Nevus

Age range

9 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Dermatology, Medical University of Graz

Graz, 8036, Austria

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

To test the frequency of BRAF and NRAS mutations among nevi

Genetic

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

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

Primary outcomes

  1. Frequency of BRAF Mutations Among Nevi

    Time frame: up to 30 months

    All nevi were analyzed for BRAF mutations using the (less sensitive) Sanger method. A random subset of nevi was also analyzed using the (more sensitive) Ultradeep pyro-sequencing method (UDPS). The frequency is reported here as the number of BRAF mutations found by each method.

Secondary outcomes

  1. Frequency of NRAS Mutations Among Nevi

    Time frame: 30 months

    All nevi were analyzed for NRAS mutations using the (less sensitive) Sanger method. The (more sensitive) Ultradeep pyro-sequencing method (UDPS) is not applicable for this mutation. The frequency is reported here as the number of NRAS mutations from the analyzed nevi.

Sponsors and collaborators

Lead sponsor

Medical University of Graz

Other

Registry information

Official study 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.

Important dates

Study start
2006
Primary completion
2009
Study completion
2010
First posted
Jan 17, 2007
Registry last updated
Jan 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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