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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.


N/A
9 Years
80 Years
Not Enrolling
Both
Nevi

Thank you

Trial Information

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.


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


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

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Frequency of BRAF Mutations Among Nevi

Outcome Description:

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.

Outcome Time Frame:

up to 30 months

Safety Issue:

No

Principal Investigator

Iris Zalaudek, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Department of Dermatology, Medical University of Graz

Authority:

Austria: Ethikkommission

Study ID:

V9-B05 (FWF)

NCT ID:

NCT00422448

Start Date:

September 2006

Completion Date:

April 2010

Related Keywords:

  • Nevi
  • Dermoscopy
  • Histopathology
  • Genetics
  • Nevi
  • Nevogenesis
  • Nevus
  • Nevus, Pigmented

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