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.

Study Overview

• Status: Recruiting
• Conditions: Melanocytic Nevi
• Intervention / Treatment: Other: Collecting Nevi

• Study Type: Observational
• Enrollment (Estimated): 50

Contacts and Locations

• Study Contact: Name: Maija Kiuru, MD; Phone Number: 916-734-0591; Email: mkiuru@ucdavis.edu
• Study Contact Backup: Name: John Robb; Phone Number: 916-551-2636; Email: jmrobb@ucdavis.edu

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95816
      • Recruiting
      • University of California-Davis, Department of Dermatology
      • Contact: John Robb; Phone Number: 916-551-2636; Email: jmrobb@ucdavis.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Genome Wide Mutation Analysis	Will be performing genome wide mutation analysis to quantify the number of mutations.	Feb 2017 - December 2018

Collaborators and Investigators

• Sponsor: University of California, Davis

Study record dates

Study Major Dates

• Study Start (Actual): June 26, 2017
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2025

Study Registration Dates

• First Submitted: February 13, 2017
• First Submitted That Met QC Criteria: February 13, 2017
• First Posted (Actual): February 15, 2017

Study Record Updates

• Last Update Posted (Estimated): December 20, 2023
• Last Update Submitted That Met QC Criteria: December 19, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Nevi and Melanomas; Nevus, Spindle Cell; Nevus; Nevus, Pigmented; Nevus, Epithelioid and Spindle Cell
• Other Study ID Numbers: 960347

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No