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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Iris Zalaudek, MD | Department of Dermatology, Medical University of Graz | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Dermatology, Medical University of Graz | Graz | 8036 | Austria |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16433800 | Background | 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. | |
| 16536840 | Background |
| Label | URL |
|---|---|
| Webpage of the sponsoring organization | View source |
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Insufficient prospective accrual of patients during the 1st year of enrollment lead to additional retrospective inclusion of a dataset of 21 paraffin-embedded tissue specimens from excised nevi .
Pigmented lesion clinic from October 2006 to March 2009
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| ID | Title | Description |
|---|---|---|
| FG000 | Nevi | with or without BRAF and NRAS |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Nevi | with or without BRAF and NRAS |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Apr 2010 | Number | BRAF mutations | up to 30 months | nevi | Participants |
|
were not collected or assessed
postoperative complications were not collected or assessed
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Nevi | with or without BRAF and NRAS |
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During first year of enrollment too few patients agreed to participate. Therefore a sample of 21 nevi were additionally retrospectively included.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Prof. Dr. Iris Zalaudek | Medical University of Graz - Austria | +436763328269 | iris.zalaudek@gmail.com |
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| ID | Term |
|---|---|
| D009506 | Nevus |
| ID | Term |
|---|---|
| D018326 | Nevi and Melanomas |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
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|
| 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. |
| 19833408 | Derived | 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. |
| Participants |
|
| Age Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Units | Counts |
|---|---|
| Participants |
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| nevi |
|
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| 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. | 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. | Posted | Apr 2010 | Number | NRAS mutations | 30 months | number of nevi | Participants |
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