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Genetic Basis 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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03054584
Recruitment Status : Recruiting
First Posted : February 15, 2017
Last Update Posted : October 30, 2019
Sponsor:
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

The objective of this protocol is to further elucidate the genetic mutations that drive melanocytic nevi (benign melanocytic neoplasms, moles). This will be performed by whole genome, whole exome, or targeted sequencing of de-identified specimens.

Herein, the investigators plan to isolate DNA from de-identified skin biopsy specimens and blood samples:

  1. From melanocytic nevi collected by skin biopsy (a shave or punch biopsy). A part of the tissue will be submitted for routine diagnostic dermatopathology and investigational histomorphologic and immunohistochemical analysis.
  2. From corresponding normal tissue (blood). DNA isolated from blood will be used as a normal control when analyzing sequencing data to identify somatic mutations in lesional tissue.

Condition or disease Intervention/treatment
Melanocytic Nevi Other: Collecting Nevi

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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Genetic Basis of Melanocytic Nevi
Actual Study Start Date : June 26, 2017
Estimated Primary Completion Date : January 2025
Estimated Study Completion Date : January 2025

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma
MedlinePlus related topics: Birthmarks Moles


Intervention Details:
  • Other: Collecting Nevi
    Will be collecting Nevi and completing a DNA analysis, no intervention will be made.


Primary Outcome Measures :
  1. Genome Wide Mutation Analysis [ Time Frame: Feb 2017 - December 2018 ]
    Will be performing genome wide mutation analysis to quantify the number of mutations.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects seen in UC Davis dermatology clinic diagnosed as having melanocytic nevi will be recruited from the clinic during their routine visit. Subjects identified in clinic will be approached after their clinic visit.
Criteria

Inclusion criteria:

  • Male or female subjects that are 18 years or older
  • Subjects with melanocytic nevi\

Exclusion criteria:

  • Patients less than 18 years of age
  • Patients without melanocytic nevi
  • Patients with a bleeding disorder or are taking anticoagulation medication

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03054584


Contacts
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Contact: Maija Kiuru, MD 916-734-0591 mkiuru@ucdavis.edu
Contact: Iryna Rybak 916-734-1509 irybak@ucdavis.edu

Locations
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United States, California
University of California-Davis, Department of Dermatology Recruiting
Sacramento, California, United States, 95816
Contact: Iryna Rybak    916-734-1509    irybak@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT03054584    
Other Study ID Numbers: 960347
First Posted: February 15, 2017    Key Record Dates
Last Update Posted: October 30, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Nevus
Nevus, Pigmented
Nevus, Epithelioid and Spindle Cell
Nevi and Melanomas
Neoplasms by Histologic Type
Neoplasms
Nevus, Spindle Cell