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

This study has been completed.
Sponsor:
Information provided by:
Medical University of Graz
ClinicalTrials.gov Identifier:
NCT00422448
First received: January 15, 2007
Last updated: December 14, 2010
Last verified: December 2010
Results First Received: April 25, 2010  
Study Type: Interventional
Study Design: Allocation: Non-Randomized;   Endpoint Classification: Bio-availability Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Basic Science
Condition: Nevi
Intervention: Genetic: To test the frequency of BRAF and NRAS mutations among nevi

  Participant Flow
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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
  Description
Nevi with or without BRAF and NRAS

Participant Flow:   Overall Study
    Nevi  
STARTED     43 [1]
COMPLETED     43  
NOT COMPLETED     0  
[1] 22 prospectively enrolled during study period and 21 retrospectively enrolled



  Baseline Characteristics
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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
  Description
Nevi with or without BRAF and NRAS

Baseline Measures
    Nevi  
Number of Participants  
[units: participants]
  43  
Age  
[units: participants]
 
<=18 years     0  
Between 18 and 65 years     43  
>=65 years     0  
Age  
[units: years]
Mean ± Standard Deviation
  39.3  ± 9.413  
Gender  
[units: participants]
 
Female     23  
Male     20  
Region of Enrollment  
[units: participants]
 
Austria     22  
Italy     21  



  Outcome Measures
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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
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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
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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
e-mail: iris.zalaudek@gmail.com


Publications:
Publications automatically indexed to this study:

Responsible Party: Department of Dermatology, Medical University of Graz Austria, Iris Zalaudek
ClinicalTrials.gov Identifier: NCT00422448     History of Changes
Other Study ID Numbers: V9-B05 (FWF)
Study First Received: January 15, 2007
Results First Received: April 25, 2010
Last Updated: December 14, 2010
Health Authority: Austria: Ethikkommission