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Neurocutaneous Melanocytosis Registry

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT04548817
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : February 10, 2022
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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).

Condition or disease
Cutaneous Melanocytic Neoplasm Large Cutaneous Melanocytic Nevi Neurocutaneous Melanocytosis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 75 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 7 Years
Official Title: Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
Actual Study Start Date : September 3, 2020
Estimated Primary Completion Date : September 3, 2027
Estimated Study Completion Date : September 3, 2027

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

Primary Outcome Measures :
  1. Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide [ Time Frame: Up to 7 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04548817

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Contact: Yasmin Khakoo, MD 212-639-8292 khakooy@mskcc.org
Contact: Sofia Haque, MD 212-639-7170 haques@MSKCC.ORG

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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Yasmin Khakoo, MD    212-639-8292      
Contact: E.         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
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Principal Investigator: Yasmin Khakoo, MD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT04548817    
Other Study ID Numbers: 20-363
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: February 10, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
large cutaneous melanocytic nevi
neurocutaneous melanocytosis
Memorial Sloan Kettering Cancer Center
Additional relevant MeSH terms:
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Nevus, Pigmented
Neurocutaneous Syndromes
Nevi and Melanomas
Neoplasms by Histologic Type
Pigmentation Disorders
Skin Diseases
Nervous System Diseases
Ectodermal Dysplasia
Abnormalities, Multiple
Congenital Abnormalities
Skin Abnormalities
Skin Diseases, Genetic
Genetic Diseases, Inborn
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue