Neurocutaneous Melanocytosis Registry

Study Purpose

This study will involve collecting information about the regular medical care you receive for large cutaneous melanocytic nevi (LCMN) or neurocutaneous melanocytosis (NCM).

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational [Patient Registry]
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04548817
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Memorial Sloan Kettering Cancer Center
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Yasmin Khakoo, MD
Principal Investigator Affiliation	Memorial Sloan Kettering Cancer Center
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Cutaneous Melanocytic Neoplasm, Large Cutaneous Melanocytic Nevi, Neurocutaneous Melanocytosis
Study Website:	View Trial Website

Arms & Interventions

Arms

: Neurocutaneous Melanocytosis

Participants will have Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Boston, Massachusetts

Status

Not yet recruiting

Address

Boston Children's Hospital (Data Analysis Only)

Boston, Massachusetts, 02115

Site Contact

Elena Hawryluk, MD

[email protected]

617-355-6117

New York, New York

Status

Recruiting

Address

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

New York, New York, 10065

Site Contact

Yasmin Khakoo, MD

[email protected]

212-639-8292

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