Clinical trial NCT04548817: Neurocutaneous Melanocytosis Registry
Official title: Prospective Registry of Patients With Neurocutaneous Melanocytosis (NCM) Including Cutaneous and CNS Involvement
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cutaneous Melanocytic Neoplasm
Large Cutaneous Melanocytic Nevi
Neurocutaneous Melanocytosis
Keywords: large cutaneous melanocytic nevi
LCMN
neurocutaneous melanocytosis
NCM
20-363
Memorial Sloan Kettering Cancer Center
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2020-09-16
Enrollment: 75
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).


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.

Primary outcomes:
measure: Collect retrospective and prospective clinical, treatment and outcome data about patients with Neurocutaneous Melanocytosis (NCM) worldwide
timeFrame: Up to 7 years
Secondary outcomes:
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital (Data Analysis Only)
state: Massachusetts
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center (All Protocol Activities)
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Yasmin Khakoo, MD
role: PRINCIPAL_INVESTIGATOR
References: