Neurocutaneous Melanocytosis Registry
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cutaneous Melanocytic Neoplasm, Large Cutaneous Melanocytic Nevi, Neurocutaneous Melanocytosis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
Overview
This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).
Primary outcome measures
- Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide [Time frame: Up to 7 years]
Eligibility criteria
Inclusion criteria
- 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.
Exclusion criteria
- Informed consent has not been provided.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 2 centers
- Boston Children's Hospital (Data Analysis Only) — Boston
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) — New York
Identifiers
NCT: NCT04548817 · 20-363