High-Risk Nevus PhenotypeNCT03080948
Risk Stratification Among Individuals Who Have Many Moles on Their Skin
An observational study of High-Risk Nevus Phenotype, run by Memorial Sloan Kettering Cancer Center at 4 sites in United States.
Trial summary
The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- High-Risk Nevus Phenotype
- What is being tested?
- survey and Saliva samples
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 73 participants
- Where
- 4 sitesUnited States
- Study dates
- 9 Mar 2017to 28 Nov 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All patients in the Melanoma Screening and Surveillance Program (MSSP).
Who may be able to join
- Patients ≥ 18 years of age
- High-risk nevus phenotype (≥ 50 nevi (≥ 2mm in size) and ≥ 1 atypical nevus)
- First presented to MSKCC for cutaneous melanoma-related care on or after April 2016
- Cases: diagnoses of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology on or after April 2016
- Cases: completion of surgical treatment of primary melanoma
- Ability to sign or verbally consent to the informed consent
Who cannot join
- Controls: Histopathologically borderline melanocytic tumors for which melanoma could not be excluded or that were treated as possible melanomas.
- Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A, CDK4, and BAP1)
- Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology
- History of acrolentiginous type of cutaneous melanoma or history of mucosal melanoma
- Cases and controls: prior administration of systemic medications known to modify nevus phenotype, including but not limited to: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
- History of limb amputation or other condition (e.g., tattoos, burns) per investigator discretion that would modify nevus phenotype
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- Physical inability to undergo total body photography or reflectance confocal microscopy imaging (that is, remain relatively still for durations of 3-5 minutes)
- Known hypersensitivity to adhesive rings used for reflectance confocal microscopy
- Inability to give informed consent
- Have skin afflicted with anther skin condition (for example, psoriasis) that would affect ability to characterize nevus phenotype (per investigator discretion)
- Familial cutaneous melanoma history (families with at least one invasive melanoma and two or more other diagnoses of invasive melanoma or pancreatic cancer among first- or second-degree relatives on the same side of the family). We will confirm melanoma family history via medical record documentation, whenever possible, as recommended by previous studies that disproved about half of the reported family histories of melanoma among first-degree relatives in case-control studies.
- Age 70 or above
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Memorial Sloan Kettering Basking Ridge
Basking Ridge, New Jersey, 07920
Memorial Sloan Kettering Westchester
Harrison, New York, 10604
Memorial Sloan Kettering Cancer Center Hauppauge
Hauppauge, New York, 11788
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: Cutaneous Melanoma Risk Stratification of Individuals With a High-Risk Nevus Phenotype
The investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.
- Conditions
- High-Risk Nevus Phenotype
- Being tested
- survey, Saliva samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surveyBehavioural
Research assessments as part of this protocol will be scheduled during routine clinic visits
Saliva samplesOther
Germline DNA analysis
| Study group | Role | What they receive |
|---|---|---|
| History of Melanoma (cases) | Participants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care. Receives: Behavioral: survey; Other: Saliva samples | |
| No Melanoma History (controls) | Participants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care. Receives: Behavioral: survey; Other: Saliva samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients having specific dermoscopic patterns
For each person, the proportions of their nevi having specific dermoscopic patterns will be calculated.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2017
- Study start9 Mar 2017
- Primary completion28 Nov 2025
- Study completion28 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High-Risk Nevus PhenotypeStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Sheba Medical Center, Tel-Aviv Sourasky Medical Center
- Responsible party
- Sponsor
- Investigators
- Allan Halpern, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03080948
- Sponsor's protocol ID
- 17-083
- Status last verified
- Dec 2025
- First submitted
- 10 Mar 2017
- Last updated
- 2 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cutaneous Melanoma Risk Stratification of Individuals With a High-Risk Nevus Phenotype
- ClinicalTrials.gov ID
- NCT03080948
- Acronym / sponsor ID
- 17-083
- Conditions
- High-Risk Nevus Phenotype
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Collaborators
- Princess Alexandra Hospital, Brisbane, Australia, Sheba Medical Center, Tel-Aviv Sourasky Medical Center
- Study start
- 9 Mar 2017 (actual)
- Primary completion
- 28 Nov 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 15 Mar 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 investigators are doing this study to improve our ability to identify which people with many moles on their skin are most likely to develop skin melanoma. The investigators hope to identify features of moles that are associated with melanoma risk. The investigators hope to use this information to customize and tailor melanoma screening to the individual patient based on a better estimate of their individual risk.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| History of Melanoma (cases) | – | Behavioral: survey, Other: Saliva samplesParticipants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care. |
| No Melanoma History (controls) | – | Behavioral: survey, Other: Saliva samplesParticipants at high-risk for melanoma (that is, those having many nevi and morphologically atypical nevi) who either have a history of invasive melanoma (cases) or do not have a history of melanoma (controls) and will perform comprehensive total body imaging of their moles in order to identify phenotypic markers of melanoma risk that aid in melanoma risk stratification. In addition, we will investigate histopathologic and molecular features of moles that are associated with melanoma risk and with melanoma subtypes. The evaluations needed for this study protocol will be primarily performed during routine clinical care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients in the Melanoma Screening and Surveillance Program (MSSP).
Key inclusion criteria (6 listed)
- Patients ≥ 18 years of age
- High-risk nevus phenotype (≥ 50 nevi (≥ 2mm in size) and ≥ 1 atypical nevus)
- First presented to MSKCC for cutaneous melanoma-related care on or after April 2016
- Cases: diagnoses of unequivocal invasive cutaneous melanomas (AJCC Stages I-IV) confirmed by MSKCC pathology on or after April 2016
- Cases: completion of surgical treatment of primary melanoma
Key exclusion criteria (12 listed)
- Controls: Histopathologically borderline melanocytic tumors for which melanoma could not be excluded or that were treated as possible melanomas.
- Known germline high-penetrance melanoma predisposition mutation (that is, CDKN2A, CDK4, and BAP1)
- Cases: history of invasive cutaneous melanoma (AJCC Stages I-IV) not confirmed by MSKCC pathology
- History of acrolentiginous type of cutaneous melanoma or history of mucosal melanoma
- Cases and controls: prior administration of systemic medications known to modify nevus phenotype, including but not limited to: MEK inhibitors (trametinib, cobimetinib, etc.), BRAF inhibitors (vemurafenib, dabrafenib, etc.), and immunotherapy (pembrolizumab, nivolumab, atezolizumab, ipilimumab, etc.). Controls: history of Stage 0-IV melanoma confirmed by MSKCC pathology
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 |
|---|---|---|
| surveyResearch assessments as part of this protocol will be scheduled during routine clinic visits | Behavioural | History of Melanoma (cases), No Melanoma History (controls) |
| Saliva samplesGermline DNA analysis | Other | History of Melanoma (cases), No Melanoma History (controls) |
Primary outcome
number of patients having specific dermoscopic patterns
Time frame: 2 years
For each person, the proportions of their nevi having specific dermoscopic patterns will be calculated.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2025.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
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. This study is not recruiting at the moment.
Allan Halpern, MD principal investigator
Memorial Sloan Kettering Cancer Center
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High-Risk Nevus Phenotype, run by Memorial Sloan Kettering Cancer Center at 4 sites 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 2 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of patients having specific dermoscopic patterns (time frame: 2 years). 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 2 Dec 2025.