Genetic Basis of Melanocytic Nevi

Melanocytic Nevi Clinical Trial

Official title:

Genetic Basis of Melanocytic Nevi

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03054584
• Other study ID #: 960347
• Status: Recruiting
• Start date: June 26, 2017
• Est. completion date: January 2025

Study information

• Verified date: December 2023
• Source: University of California, Davis
• Contact: Maija Kiuru, MD
• Phone: 916-734-0591
• Email: mkiuru[@]ucdavis.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: January 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Melanocytic Nevi
• Nevus
• Nevus, Pigmented

Intervention

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

Locations

Country	Name	City	State
United States	University of California-Davis, Department of Dermatology	Sacramento	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Genome Wide Mutation Analysis	Will be performing genome wide mutation analysis to quantify the number of mutations.	Feb 2017 - December 2018