Cutaneous Melanocytic NeoplasmNCT04548817
Neurocutaneous Melanocytosis Registry
An observational study of Cutaneous Melanocytic Neoplasm and Large Cutaneous Melanocytic Nevi, run by Memorial Sloan Kettering Cancer Center at 2 sites in United States.
Trial summary
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cutaneous Melanocytic Neoplasm, Large Cutaneous Melanocytic Nevi, Neurocutaneous Melanocytosis
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 3 Sep 2020to 3 Sep 2027
- How long will I take part?
- 7 Years
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: A target sample of 75 patients with LCMN and/or NCM will be enrolled in this registry study. The study is expected to accrue over ≥ 7 years. Currently, an estimated 50 LCMN patients are followed at MSK and we anticipate 25 or more to be referred from outside providers or from new patients seen at MSK. The patient population and the MSK referral base is growing at this time, making this enrollment goal as feasible.
Who may be able to join
- Patients with LCMN, defined as:
- Dark-colored patch of skin present at birth
- Can be located anywhere on the individual's skin
- May include satellite lesions
- May be associated with hypertrichosis
- OR, in absence of cutaneous involvement:
Show all 11Show fewer
- histologically or radiographically confirmed CNS melanocytosis.
- Any age at diagnosis.
- Signed informed consent by a patient, or parent/legal guardian.
- Deceased patients can be included provided that parent/legal guardian is contacted at least 6 months after the death of the child and not on the child's birthday or anniversary of death.
- Pathology review at MSK is not mandatory to confirm the diagnosis of LCMN or NCM. We will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. However, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis.
Who cannot join
- Informed consent has not been provided.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Not yet recruiting
Boston Children's Hospital (Data Analysis Only)
Boston, Massachusetts, 02115
Elena Hawryluk, MD, 617-355-6117
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065
Yasmin Khakoo, MD, 212-639-8292
About this study
Official title: Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).
- Conditions
- Cutaneous Melanocytic Neoplasm, Large Cutaneous Melanocytic Nevi, Neurocutaneous Melanocytosis
- Keywords
- large cutaneous melanocytic nevi, LCMN, neurocutaneous melanocytosis, NCM, 20-363, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Neurocutaneous melanosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Neurocutaneous Melanocytosis | Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide
Measured: Up to 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2020
- Study start3 Sep 2020
- Primary completion3 Sep 2027 (estimated)
- Study completion3 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutaneous Melanocytic NeoplasmStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
- Target duration
- 7 Years
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yasmin Khakoo, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04548817
- Sponsor's protocol ID
- 20-363
- Status last verified
- Sep 2026
- First submitted
- 8 Sep 2020
- Last updated
- 5 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
- ClinicalTrials.gov ID
- NCT04548817
- Acronym / sponsor ID
- 20-363
- Conditions
- Cutaneous Melanocytic Neoplasm, Large Cutaneous Melanocytic Nevi, Neurocutaneous Melanocytosis
- Keywords
- large cutaneous melanocytic nevi, LCMN, neurocutaneous melanocytosis, NCM, 20-363, Memorial Sloan Kettering Cancer Center
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 3 Sep 2020 (actual)
- Primary completion
- 3 Sep 2027 (estimated)
- Study completion
- 3 Sep 2027 (estimated)
- First posted
- 16 Sep 2020 (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.
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 7 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurocutaneous Melanocytosis | – | –Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- A target sample of 75 patients with LCMN and/or NCM will be enrolled in this registry study. The study is expected to accrue over ≥ 7 years. Currently, an estimated 50 LCMN patients are followed at MSK and we anticipate 25 or more to be referred from outside providers or from new patients seen at MSK. The patient population and the MSK referral base is growing at this time, making this enrollment goal as feasible.
Key inclusion criteria (11 listed)
- Patients with LCMN, defined as:
- histologically or radiographically confirmed CNS melanocytosis.
- Pathology review at MSK is not mandatory to confirm the diagnosis of LCMN or NCM. We will not require pathology analysis of leptomeningeal deposits in patients where characteristic skin lesions are present and melanosis of the meninges is radiographically evident. However, if pathology samples have already been obtained as part of a patient's evaluation and treatment at another institution, tissue samples will be requested for review and confirmation of the diagnosis.
Key exclusion criteria (1 listed)
- Informed consent has not been provided.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide
Time frame: Up to 7 years
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 5 Oct 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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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.
Yasmin Khakoo, MD principal investigator
Memorial Sloan Kettering Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cutaneous Melanocytic Neoplasm and Large Cutaneous Melanocytic Nevi, run by Memorial Sloan Kettering Cancer Center at 2 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 11 inclusion and 1 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 5 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
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 Yasmin Khakoo, MD (212-639-8292, khakooy@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide (time frame: Up to 7 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 5 Oct 2026.