NeviNCT00422448

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

A study testing To test the frequency of BRAF and NRAS mutations among nevi in people with Nevi, run by Medical University of Graz at 1 site in Austria.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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). Read more about this study

Who is it for?: Ages 9 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Nevi
What is being tested?: To test the frequency of BRAF and NRAS mutations among nevi
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteAustria
Study dates: Sep 2006to Apr 2010
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 80 years
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Austria1 site

Department of Dermatology, Medical University of Graz
Graz, 8036

Other trials in Austria

About this study

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.

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.

Read the detailed 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

Conditions: Nevi
Being tested: To test the frequency of BRAF and NRAS mutations among nevi
Keywords: Dermoscopy, Histopathology, Genetics, Nevi, Nevogenesis
Medical subject headings: Nevus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

To test the frequency of BRAF and NRAS mutations among neviGenetic
Also called NM_004333; Homo sapiens v-raf murine sarcoma viral oncogene homolog B1
Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations

Study groups in NCT00422448
Study group	Role	What they receive
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 Receives: Genetic: To test the frequency of BRAF and NRAS mutations among nevi

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: up to 30 months

Secondary outcomes (1)

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.
Measured: 30 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2006Apr 2010

First posted17 Jan 2007 (estimated)
Study startSep 2006
Primary completionMar 2009
Study completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (3)Papers the sponsor has linked to this study.
Other trials for NeviStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00422448
Sponsor's protocol ID: V9-B05 (FWF)
Status last verified: Dec 2010
First submitted: 15 Jan 2007
Last updated: 14 Jan 2011
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Publications

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.
PubMed 16433800
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.
PubMed 16536840
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.
PubMed 19833408

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Enrolling by invitationObservational study
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Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
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Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Active, not recruitingPhase 2/3
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7

All Nevi trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.

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.
ClinicalTrials.gov ID: NCT00422448
Acronym / sponsor ID: V9-B05 (FWF)
Conditions: Nevi
Keywords: Dermoscopy, Histopathology, Genetics, Nevi, Nevogenesis
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Medical University of GrazUniversity, hospital or other
Study start: Sep 2006
Primary completion: Mar 2009 (actual)
Study completion: Apr 2010 (actual)
First posted: 17 Jan 2007 (estimated)
Results: Posted 14 Jan 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Basic science
Allocation: Non-randomised
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Nevi from participants	Experimental	Genetic: To test the frequency of BRAF and NRAS mutations among neviBenign 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

Who may qualify

Ages: 9 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (1 listed)

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

Key exclusion criteria (5 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
To test the frequency of BRAF and NRAS mutations among neviAlso: NM_004333; Homo sapiens v-raf murine sarcoma viral oncogene homolog B1Benign nevi excised for the study purpose where genetically analyzed for the presence/absence of BRAF and NRAS mutations	Genetic	Nevi from participants

Primary outcome

Frequency of BRAF Mutations Among Nevi
Time frame: up to 30 months
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.

1 secondary outcome

Frequency of NRAS Mutations Among Nevi
Time frame: 30 months

Results and safety

Results posted to the registry on 14 Jan 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Nevi	43	43

Primary outcome: Frequency of BRAF Mutations Among Nevi

Time frame: up to 30 months. Number. Unit: BRAF mutations

Measure	Nevi n = 43
Sanger method (n=45)	6
UDPS (n=24)	19

Population analysed: 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.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: were not collected or assessed. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Nevi	0 of 0	0 of 0	Not reported

Limitations and caveats (from the sponsor): During first year of enrollment too few patients agreed to participate. Therefore a sample of 21 nevi were additionally retrospectively included.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2011.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 16433800Zalaudek 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.
Background: PubMed 16536840Zalaudek 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.
Derived from this study: PubMed 19833408Pellacani 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.
Webpage of the sponsoring organizationLink provided by the sponsor.

Related trials for Nevi

Enrolling by invitationObservational study
Community Based Strategies for Early Detection of Melanoma
Melanoma
Active, not recruitingPhase 3
Dabrafenib and Trametinib Followed by Ipilimumab and Nivolumab or Ipilimumab and Nivolumab Followed by Dabrafenib and Trametinib in Treating Patients With Stage III-IV BRAFV600 Melanoma
Clinical Stage III Cutaneous Melanoma AJCC v8, Clinical Stage IV Cutaneous Melanoma AJCC v8
RecruitingObservational study
Clinical, Laboratory, and Epidemiologic Characterization of Individuals and Families at High Risk of Melanoma
Melanoma, Dysplastic Nevus Syndrome
RecruitingObservational study
Evaluation for NCI Surgery Branch Clinical Research Protocols
Synovial Cell Cancer, Melanoma
Active, not recruitingPhase 2/3
A Phase II/III Trial of Nivolumab, Ipilimumab, and GM-CSF in Patients With Advanced Melanoma
Stage III Cutaneous Melanoma AJCC v7, Stage IV Cutaneous Melanoma AJCC v6 and v7

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Iris Zalaudek, MD study chair

Department of Dermatology, Medical University of Graz

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing To test the frequency of BRAF and NRAS mutations among nevi in people with Nevi, run by Medical University of Graz at 1 site in Austria.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Austria. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jan 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Frequency of BRAF Mutations Among Nevi (time frame: up to 30 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00422448, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2011.