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

Nevi Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00422448
• Other study ID #: V9-B05 (FWF)
• Status: Completed
• Phase: N/A
• First received: January 15, 2007
• Last updated: December 14, 2010
• Start date: September 2006
• Est. completion date: April 2010

Study information

• Verified date: December 2010
• Source: Medical University of Graz
• Contact: n/a
• Is FDA regulated: No
• Health authority: Austria: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 43
• Est. completion date: April 2010
• Est. primary completion date: March 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 9 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Nevi
• Nevus
• Nevus, Pigmented

Intervention

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

Locations

Country	Name	City	State
Austria	Department of Dermatology, Medical University of Graz	Graz

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Graz

Country where clinical trial is conducted

Austria, 

References & Publications (2)

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Frequency of NRAS Mutations Among Nevi	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.	30 months	No

External Links

•   Webpage of the sponsoring organization