Genetic Basis of Melanocytic Nevi

Sponsor

University of California, Davis (Other)

Overall Status

Recruiting

CT.gov ID

NCT03054584

Collaborator

(none)

Enrollment

Location

90.2

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

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:

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.
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	Phase
Melanocytic Nevi	Other: Collecting Nevi

Study Design

Study Type:

Observational

Anticipated Enrollment :

50 participants

Observational Model:

Other

Time Perspective:

Prospective

Official Title:

Genetic Basis of Melanocytic Nevi

Actual Study Start Date :

Jun 26, 2017

Anticipated Primary Completion Date :

Jan 1, 2025

Anticipated Study Completion Date :

Jan 1, 2025

Outcome Measures

Primary Outcome Measures

Genome Wide Mutation Analysis [Feb 2017 - December 2018]
Will be performing genome wide mutation analysis to quantify the number of mutations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California-Davis, Department of Dermatology	Sacramento	California	United States	95816

Sponsors and Collaborators

University of California, Davis

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, Davis

ClinicalTrials.gov Identifier:

NCT03054584

Other Study ID Numbers:

960347

First Posted:

Feb 15, 2017

Last Update Posted:

Nov 17, 2021

Last Verified:

Nov 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nevus

Nevus, Pigmented

Nevus, Epithelioid and Spindle Cell

Study Results

No Results Posted as of Nov 17, 2021