Melanocytic NeviNCT03054584
Genetic Basis of Melanocytic Nevi
An observational study of Melanocytic Nevi, run by University of California, Davis at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Melanocytic Nevi
- What is being tested?
- Collecting Nevi
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 26 Jun 2017to Jun 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Male or female subjects that are 18 years or older
- Subjects with melanocytic nevi\
Who cannot join
- Patients less than 18 years of age
- Patients without melanocytic nevi
- Patients with a bleeding disorder or are taking anticoagulation medication
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of California-Davis, Department of Dermatology
Sacramento, California, 95816
John Robb, 916-551-2636, jmrobb@ucdavis.edu
About this study
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.
- Conditions
- Melanocytic Nevi
- Being tested
- Collecting Nevi
- Medical subject headings
- Nevus, Pigmented
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collecting NeviOther
Will be collecting Nevi and completing a DNA analysis, no intervention will be made.
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome Wide Mutation Analysis
Will be performing genome wide mutation analysis to quantify the number of mutations.
Measured: Feb 2017 - December 2018
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2017
- Study start26 Jun 2017
- Primary completionJun 2028 (estimated)
- Study completionJun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanocytic NeviStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03054584
- Sponsor's protocol ID
- 960347
- Status last verified
- Sep 2026
- First submitted
- 13 Feb 2017
- Last updated
- 17 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Basis of Melanocytic Nevi
- ClinicalTrials.gov ID
- NCT03054584
- Acronym / sponsor ID
- 960347
- Conditions
- Melanocytic Nevi
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Study start
- 26 Jun 2017 (actual)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2028 (estimated)
- First posted
- 15 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- Male or female subjects that are 18 years or older
- Subjects with melanocytic nevi\
Key exclusion criteria (3 listed)
- Patients less than 18 years of age
- Patients without melanocytic nevi
- Patients with a bleeding disorder or are taking anticoagulation medication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Collecting NeviWill be collecting Nevi and completing a DNA analysis, no intervention will be made. | Other | – |
Primary outcome
Genome Wide Mutation Analysis
Time frame: Feb 2017 - December 2018
Will be performing genome wide mutation analysis to quantify the number of mutations.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Melanocytic Nevi, run by University of California, Davis at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Maija Kiuru, MD (916-734-0591, mkiuru@ucdavis.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genome Wide Mutation Analysis (time frame: Feb 2017 - December 2018). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Sep 2026.