N/A
N=43
Study to Test Genetic Alterations Among Different Dermoscopic Types of Melanocytic Nevi.
Nevi
Bottom Line
View on ClinicalTrials.gov: NCT00422448 ↗Enrolled (actual)
43
Serious AEs
—
Results posted
Jan 2011
Primary outcome: Primary: Frequency of BRAF Mutations Among Nevi — 6; 19 BRAF mutations
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- To test the frequency of BRAF and NRAS mutations among nevi (Genetic)
- Age
- Pediatric, Adult, Older Adult · 9+ yrs
- Sex
- All
- Sponsor
- Medical University of Graz
- Primary completion
- Mar 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Frequency of BRAF Mutations Among Nevi |
6; 19 | — |
| SECONDARY Frequency of NRAS Mutations Among Nevi |
— | — |
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.
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00422448). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.