Status:
COMPLETED
Natural History Study of Moles and Suspicious Melanoma
Lead Sponsor:
National Cancer Institute (NCI)
Conditions:
Melanocytic Nevi
Acquired Melanocytic Nevi
Eligibility:
All Genders
5+ years
Brief Summary
Background: * Melanocytic nevi, or "moles," are non-cancerous growths of a type of skin cell called a melanocyte. * Large congenital melanocytic nevi (LCMN) are a special type of mole that begins to ...
Detailed Description
The objective of this study is to understand early transformation and malignant progression events of cutaneous melanoma by obtaining detailed clinical information and lesional tissue for analysis, ce...
Eligibility Criteria
Inclusion
- INCLUSION CRITERIA:
- Infants/Children
- Must be less than or equal to 5 years.
- Must have large congenital melanocytic nevus (LCMN, diagnosed clinically or by biopsy) that is greater than 20 cm in any one dimension or that is greater than 8 cm in any one dimension involving the scalp.
- Must have outside referring physician.
- OR
- Adults
- Must be greater than 18 years.
- Must have greater than or equal to 100 melanocytic nevi greater than 2 mm in diameter.
- Must have at least one melanocytic nevus greater than or equal to 4 mm in longest dimension.
- Can have prior history of cutaneous or ocular malignant melanoma.
- Must have outside primary physician.
- OR
- Adults
- Must be greater than 18 years.
- Must have a current pigmented lesion clinically suspicious for primary melanoma.
- Must have outside primary physician.
- AND
- All patients, or in the case of infants and children their parents or legal guardians, must be able to understand and sign an informed consent.
- EXCLUSION CRITERIA:
- The patient does not meet the inclusion criteria.
- Diagnosis of genetic syndrome associated with multiple lentigines or nevi (Peutz-Jeghers syndrome, Carney complex, turner syndrome, Noonan's syndrome).
- Two or more first-degree relatives with history of cutaneous melanoma and familial atypical mole-melanoma syndrome phenotype.
- Diagnosis of cancer-associated syndrome (xeroderma pigmentosum, type I neurofibromatosis, Li-Fraumeni syndrome).
- Inability to tolerate surgical procedure due to bleeding diathesis or disorder or other cause as determined by principal investigator.
- Patient is unwilling to consider elective biopsy of a melanocytic nevus.
Exclusion
Key Trial Info
Start Date :
February 3 2006
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 31 2011
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT00288938
Start Date
February 3 2006
End Date
October 31 2011
Last Update
July 2 2017
Active Locations (1)
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1
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892