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NCT Number: NCT03054584

Genetic Basis of Melanocytic Nevi

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.

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Key information

Conditions

Melanocytic Nevi Neoplasms Neoplasms by Histologic Type Nevi and Melanomas Nevus Nevus, Pigmented

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

Location status: Recruiting

Location contact

John Robb

CONTACT

[email protected]

916-551-2636

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Collecting Nevi

Other

Will be collecting Nevi and completing a DNA analysis, no intervention will be made.

Primary outcomes

  1. Genome Wide Mutation Analysis

    Time frame: Feb 2017 - December 2018

    Will be performing genome wide mutation analysis to quantify the number of mutations.

Study contacts

Contact information is provided by the study sponsor or research team.

John Robb

CONTACT

[email protected]

916-551-2636

Maija Kiuru, MD

CONTACT

[email protected]

916-734-0591

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Important dates

Study start
2017
Primary completion
2028
Study completion
2028
First posted
Feb 15, 2017
Registry last updated
Sep 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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