An interventional study of To test the frequency of BRAF and NRAS mutations among nevi in Nevi, sponsored by Medical University of Graz. Completed at 1 site in Austria. Open to participants aged 9 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2011-01-14.
Sponsored by Medical University of Graz · Not applicable, Interventional, and Basic science
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
47 studies on the registry are indexed under Nevus; 9 are open to participants now.
This study's enrollment of 43 is below the median of 100 across 19 interventional studies indexed under Nevus.
Browse Nevus studies →Medical University of Graz is the lead sponsor of 471 studies on the registry; 98 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
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Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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.
Time frame: up to 30 months
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.
Time frame: 30 months
Pigmented lesion clinic from October 2006 to March 2009
| Milestone | Nevi |
|---|---|
| Started | 43 |
| Completed | 43 |
| Not completed | 0 |
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.
| BRAF mutations | Nevi |
|---|---|
| Sanger method (n=45) | 6 |
| UDPS (n=24) | 19 |
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.
| NRAS mutations | Nevi |
|---|---|
| Frequency of NRAS Mutations Among Nevi | 0 |
Collected over were not collected or assessed. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nevi | — | — | — |
| Age, Categorical(Participants) | Nevi |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 43 |
| >=65 years | 0 |
| Age Continuous(years) | Nevi |
|---|---|
| Mean | 39.3 ± 9.413 |
| Sex: Female, Male(Participants) | Nevi |
|---|---|
| Female | 23 |
| Male | 20 |
| Region of Enrollment(participants) | Nevi |
|---|---|
| Austria | 22 |
| Italy | 21 |
The record gives a start of Sep 2006, a primary completion of Mar 2009 and a completion of Apr 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jan 2011, 1 year 10 months after primary completion.
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This study is completed, as verified in Dec 2010. You cannot join it, but the record below documents what was studied.
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