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

NCT00422448 | Completed Results DMC

• 1 other identifier: V9-B05 (FWF)
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Nevi

Keywords

Dermoscopy; Histopathology; Genetics; Nevi; Nevogenesis

Outcome Measures

Primary Outcomes (1)

• Frequency of BRAF Mutations Among Nevi

  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.

  up to 30 months

Secondary Outcomes (1)

• Frequency of NRAS Mutations Among Nevi

  30 months

Study Arms (1)

Nevi from participants

EXPERIMENTAL

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

Interventions

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

Also known as: NM_004333; Homo sapiens v-raf murine sarcoma viral oncogene homolog B1

Nevi from participants

Eligibility Criteria

• Age: 9 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (1)

Department of Dermatology, Medical University of Graz

Graz, 8036, Austria

Location

Related Publications (3)

• Zalaudek I, Grinschgl S, Argenziano G, Marghoob AA, Blum A, Richtig E, Wolf IH, Fink-Puches R, Kerl H, Soyer HP, Hofmann-Wellenhof R. Age-related prevalence of dermoscopy patterns in acquired melanocytic naevi. Br J Dermatol. 2006 Feb;154(2):299-304. doi: 10.1111/j.1365-2133.2005.06973.x.

  PMID: 16433800 BACKGROUND

• Zalaudek I, Hofmann-Wellenhof R, Soyer HP, Ferrara G, Argenziano G. Naevogenesis: new thoughts based on dermoscopy. Br J Dermatol. 2006 Apr;154(4):793-4. doi: 10.1111/j.1365-2133.2006.07152.x. No abstract available.

  PMID: 16536840 BACKGROUND

• Pellacani G, Scope A, Ferrari B, Pupelli G, Bassoli S, Longo C, Cesinaro AM, Argenziano G, Hofmann-Wellenhof R, Malvehy J, Marghoob AA, Puig S, Seidenari S, Soyer HP, Zalaudek I. New insights into nevogenesis: in vivo characterization and follow-up of melanocytic nevi by reflectance confocal microscopy. J Am Acad Dermatol. 2009 Dec;61(6):1001-13. doi: 10.1016/j.jaad.2009.04.018. Epub 2009 Oct 14.

  PMID: 19833408 DERIVED

Related Links

• Webpage of the sponsoring organization

MeSH Terms

Conditions

Nevus

Condition Hierarchy (Ancestors)

Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Limitations and Caveats

During first year of enrollment too few patients agreed to participate. Therefore a sample of 21 nevi were additionally retrospectively included.

Results Point of Contact

• Title: Prof. Dr. Iris Zalaudek
• Organization: Medical University of Graz - Austria

iris.zalaudek@gmail.com

+436763328269

Study Officials

• Iris Zalaudek, MD

  Department of Dermatology, Medical University of Graz

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 15, 2007
• First Posted: January 17, 2007
• Study Start: September 1, 2006
• Primary Completion: March 1, 2009
• Study Completion: April 1, 2010
• Last Updated: January 14, 2011
• Results First Posted: January 14, 2011

Record last verified: 2010-12

Locations

AU (1)