Natural History Study of Moles and Suspicious Melanoma
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ClinicalTrials.gov Identifier: NCT00288938 |
Recruitment Status :
Completed
First Posted : February 8, 2006
Last Update Posted : July 2, 2017
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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 grow before birth and is larger than moles that develop after birth.
- Determining how melanocytes in moles and LCMNs differ from normal melanocytes may increase the ability to predict whether a mole will give rise to a melanoma (a type of skin cancer)
Objectives:
- To understand how melanomas develop, by studying moles, LCMNs, and pigmented skin lesions that are suspicious for melanoma
- To develop better criteria for diagnosing melanoma, particularly by using a device called a digital dermatoscope (a special camera, connected to a computer, that takes pictures of moles when they are magnified and illuminated)
Eligibility:
- Children 5 years old or older with an LCMN
- Adults 18 years old or older with 100 or more moles larger than 2 mm in diameter and at least one 4 mm or more
- Adults 18 years old or older with a pigmented lesion suspicious for melanoma
Design:
- Patients' personal and family health history is obtained.
- Patients are examined by investigative team doctors, and several lesions are examined with a dermatoscope.
- Additional photographs of part or all of the skin surface may be taken.
- Some lesions may be biopsied.
- Additional tests or examinations may be recommended.
- Patients are followed periodically for skin or physical examinations, photography, laboratory and imaging evaluations, and possible skin biopsies.
- Children may undergo brain magnetic resonance imaging (MRI)
Condition or disease |
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Melanocytic Nevi Acquired Melanocytic Nevi Primary Cutaneous Melanoma |
Study Type : | Observational |
Actual Enrollment : | 20 participants |
Official Title: | Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma |
Study Start Date : | February 3, 2006 |
Study Completion Date : | October 31, 2011 |
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Ages Eligible for Study: | 5 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
- 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.
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): NCT00288938
United States, Maryland | |
National Institutes of Health Clinical Center, 9000 Rockville Pike | |
Bethesda, Maryland, United States, 20892 |
ClinicalTrials.gov Identifier: | NCT00288938 |
Obsolete Identifiers: | NCT00335530 |
Other Study ID Numbers: |
060060 06-C-0060 |
First Posted: | February 8, 2006 Key Record Dates |
Last Update Posted: | July 2, 2017 |
Last Verified: | October 31, 2011 |
Suspicious mole Congenital Nevus Skin Cancer |
Moles Pigmented lesion LCMN |
Melanoma Melanoma, Cutaneous Malignant Nevus Nevus, Pigmented Nevus, Epithelioid and Spindle Cell Neuroendocrine Tumors Neuroectodermal Tumors Neoplasms, Germ Cell and Embryonal |
Neoplasms by Histologic Type Neoplasms Neoplasms, Nerve Tissue Nevi and Melanomas Skin Neoplasms Neoplasms by Site Skin Diseases Nevus, Spindle Cell |