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Natural History Study of Moles and Suspicious Melanoma

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. Read our disclaimer for details. Identifier: NCT00288938
Recruitment Status : Completed
First Posted : February 8, 2006
Last Update Posted : July 2, 2017
Information provided by:
National Institutes of Health Clinical Center (CC)

Brief Summary:


  • 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)


  • 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)


  • 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


  • 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
Melanocytic Nevi Acquired Melanocytic Nevi Primary Cutaneous Melanoma

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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

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Melanoma

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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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


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.



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.



Must be greater than 18 years.

Must have a current pigmented lesion clinically suspicious for primary melanoma.

Must have outside primary physician.


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.


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.

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 identifier (NCT number): NCT00288938

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United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Layout table for additonal information Identifier: NCT00288938    
Obsolete Identifiers: NCT00335530
Other Study ID Numbers: 060060
First Posted: February 8, 2006    Key Record Dates
Last Update Posted: July 2, 2017
Last Verified: October 31, 2011
Keywords provided by National Institutes of Health Clinical Center (CC):
Suspicious mole
Congenital Nevus
Skin Cancer
Pigmented lesion
Additional relevant MeSH terms:
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Melanoma, Cutaneous Malignant
Nevus, Pigmented
Nevus, Epithelioid and Spindle Cell
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms, Nerve Tissue
Nevi and Melanomas
Skin Neoplasms
Neoplasms by Site
Skin Diseases
Nevus, Spindle Cell