Genetic Basis of Melanocytic Nevi

NCT03054584 | Recruiting

• 1 other identifier: 960347
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Melanocytic Nevi

Outcome Measures

Primary Outcomes (1)

• Genome Wide Mutation Analysis

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

  Feb 2017 - December 2018

Interventions

Collecting Nevi OTHER

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of California, Davis: lead

Study Sites (1)

University of California-Davis, Department of Dermatology

Sacramento, California, 95816, United States

RECRUITING

MeSH Terms

Conditions

Nevus, Pigmented

Condition Hierarchy (Ancestors)

Nevus; Nevi and Melanomas; Neoplasms by Histologic Type; Neoplasms

Central Study Contacts

Maija Kiuru, MD

CONTACT

916-734-0591; mkiuru@ucdavis.edu

John Robb

CONTACT

916-551-2636; jmrobb@ucdavis.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 13, 2017
• First Posted: February 15, 2017
• Study Start: June 26, 2017
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)