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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00422448
First received: January 15, 2007
Last updated: December 14, 2010
Last verified: December 2010
History of Changes
  Purpose

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.


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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Medical University of Graz:

Primary Outcome Measures:
  • Frequency of BRAF Mutations Among Nevi [ Time Frame: up to 30 months ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Frequency of NRAS Mutations Among Nevi [ Time Frame: 30 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 43
Study Start Date: September 2006
Study Completion Date: April 2010
Primary Completion Date: March 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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
 Genetic: 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
Other Name: NM_004333; Homo sapiens v-raf murine sarcoma viral oncogene homolog B1

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

Ages Eligible for Study:   9 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00422448

Locations
Austria
Department of Dermatology, Medical University of Graz
Graz, Austria, 8036
Sponsors and Collaborators
Medical University of Graz
Investigators
Study Chair: Iris Zalaudek, MD Department of Dermatology, Medical University of Graz
  More Information

Additional Information:
Webpage of the sponsoring organization  This link exits the ClinicalTrials.gov site

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Department of Dermatology, Medical University of Graz Austria, Iris Zalaudek
ClinicalTrials.gov Identifier: NCT00422448     History of Changes
Other Study ID Numbers: V9-B05 (FWF)
Study First Received: January 15, 2007
Results First Received: April 25, 2010
Last Updated: December 14, 2010
Health Authority: Austria: Ethikkommission

Keywords provided by Medical University of Graz:
Dermoscopy
Histopathology
Genetics
Nevi
Nevogenesis

Additional relevant MeSH terms:
Nevus
Nevus, Pigmented
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms

ClinicalTrials.gov processed this record on May 16, 2013