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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00288938 |
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Date of registration:
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08/02/2006 |
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Primary sponsor: |
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Public title:
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Natural History Study of Moles and Suspicious Melanoma
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Scientific title:
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Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma |
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Date of first enrolment:
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February 2006 |
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Target sample size:
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20 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00288938 |
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Study type:
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Observational |
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Study design:
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N/A
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Countries of recruitment
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United States
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Key inclusion & exclusion criteria
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- 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.
Age minimum:
5 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acquired Melanocytic Nevi
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Melanocytic Nevi
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Primary Cutaneous Melanoma
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Secondary ID(s)
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06-C-0060
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060060
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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