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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00422448
Recruitment Status : Completed
First Posted : January 17, 2007
Results First Posted : January 14, 2011
Last Update Posted : January 14, 2011
Information provided by:
Medical University of Graz

Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Basic Science
Condition: Nevi
Intervention: Genetic: To test the frequency of BRAF and NRAS mutations among nevi

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Pigmented lesion clinic from October 2006 to March 2009

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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 .

Reporting Groups
Nevi with or without BRAF and NRAS

Participant Flow:   Overall Study
STARTED   43 [1] 
[1] 22 prospectively enrolled during study period and 21 retrospectively enrolled

  Baseline Characteristics

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
Nevi with or without BRAF and NRAS

Baseline Measures
Overall Participants Analyzed 
[Units: Participants]
[Units: Participants]
<=18 years   0 
Between 18 and 65 years   43 
>=65 years   0 
[Units: Years]
Mean (Standard Deviation)
 39.3  (9.413) 
[Units: Participants]
Female   23 
Male   20 
Region of Enrollment 
[Units: Participants]
Austria   22 
Italy   21 

  Outcome Measures

1.  Primary:   Frequency of BRAF Mutations Among Nevi   [ Time Frame: up to 30 months ]

2.  Secondary:   Frequency of NRAS Mutations Among Nevi   [ Time Frame: 30 months ]

  Serious Adverse Events

  Other Adverse Events

  Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
During first year of enrollment too few patients agreed to participate. Therefore a sample of 21 nevi were additionally retrospectively included.

  More Information

Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:  
Name/Title: Prof. Dr. Iris Zalaudek
Organization: Medical University of Graz - Austria
phone: +436763328269

Publications automatically indexed to this study by Identifier (NCT Number):

Responsible Party: Department of Dermatology, Medical University of Graz Austria, Iris Zalaudek Identifier: NCT00422448     History of Changes
Other Study ID Numbers: V9-B05 (FWF)
First Submitted: January 15, 2007
First Posted: January 17, 2007
Results First Submitted: April 25, 2010
Results First Posted: January 14, 2011
Last Update Posted: January 14, 2011