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

January 15, 2007
December 14, 2010
September 2006
March 2009   (final data collection date for primary outcome measure)
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.
Not Provided
Complete list of historical versions of study NCT00422448 on ClinicalTrials.gov Archive Site
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.
Not Provided
Not Provided
Not Provided
 
Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.
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.

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.

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

Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Bio-availability Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Nevi
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
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
Intervention: Genetic: To test the frequency of BRAF and NRAS mutations among nevi

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
43
April 2010
March 2009   (final data collection date for primary outcome measure)

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
Both
9 Years to 80 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Austria
 
NCT00422448
V9-B05 (FWF)
Yes
Department of Dermatology, Medical University of Graz Austria, Iris Zalaudek
Medical University of Graz
Not Provided
Study Chair: Iris Zalaudek, MD Department of Dermatology, Medical University of Graz
Medical University of Graz
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP