Neurocutaneous Melanocytosis Registry
Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
1 other identifier
observational
100
1 country
2
Brief Summary
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Sep 2020
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 3, 2020
CompletedFirst Submitted
Initial submission to the registry
September 8, 2020
CompletedFirst Posted
Study publicly available on registry
September 16, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 3, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 3, 2027
September 30, 2025
September 1, 2025
7 years
September 8, 2020
September 29, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide
Up to 7 years
Study Arms (1)
Neurocutaneous Melanocytosis
Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
Eligibility Criteria
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.
You may qualify if:
- 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:
- 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.
You may not qualify if:
- Informed consent has not been provided.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Boston Children's Hospital (Data Analysis Only)
Boston, Massachusetts, 02115, United States
Memorial Sloan Kettering Cancer Center (All Protocol Activities)
New York, New York, 10065, United States
Related Links
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Yasmin Khakoo, MD
Memorial Sloan Kettering Cancer Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 7 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 8, 2020
First Posted
September 16, 2020
Study Start
September 3, 2020
Primary Completion (Estimated)
September 3, 2027
Study Completion (Estimated)
September 3, 2027
Last Updated
September 30, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
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.