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Recruiting

NCT Number: NCT04548817

Neurocutaneous Melanocytosis Registry

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

Recruiting

Interested in participating?

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Boston Children's Hospital (Data Analysis Only), Boston, Massachusetts, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide

    Time frame: Up to 7 years

Study contacts

Contact information is provided by the study sponsor or research team.

Sofia Haque, MD

CONTACT

[email protected]

212-639-7170

Yasmin Khakoo, MD

CONTACT

[email protected]

212-639-8292

Sponsors and collaborators

Lead sponsor

Memorial Sloan Kettering Cancer Center

Other

Registry information

Official study title

Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement

Important dates

Study start
2020
Primary completion
2027
Study completion
2027
First posted
Sep 16, 2020
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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