Recruiting

Observational Study

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT04548817

Conditions

Cutaneous Melanocytic Neoplasm

Large Cutaneous Melanocytic Nevi

Neurocutaneous Melanocytosis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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).

Conditions

Cutaneous Melanocytic Neoplasm

Large Cutaneous Melanocytic Nevi

Neurocutaneous Melanocytosis

Study ID

NCT04548817

Start date

Sep 3, 2020

Status verified date

Sep, 2025

Completion date

Sep 3, 2027

Anticipated

Primary completion date

Sep 3, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Neurocutaneous Melanocytosis

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

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 ]

Central Contacts and Locations

Central contacts

Locations

Memorial Sloan Kettering Cancer Center (All Protocol Activities)

Recruiting

New York, New York, United States, 10065

Contacts

Yasmin Khakoo, MD

212-639-8292

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

Sep 30, 2025

Last verified

Sep, 2025

Keywords

  • large cutaneous melanocytic nevi
  • LCMN
  • neurocutaneous melanocytosis
  • NCM
  • 20-363
  • Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2025-09-30.