Natural History Study of Moles and Suspicious Melanoma

This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00288938
First received: February 8, 2006
Last updated: November 1, 2011
Last verified: October 2011
  Purpose

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
Melanocytic Nevi
Acquired Melanocytic Nevi
Primary Cutaneous Melanoma

Study Type: Observational
Official Title: Dermoscopic Diagnosis, Histopathological Correlation, and Cellular Immortalization of Melanocytic Nevi and Primary Cutaneous Melanoma

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Enrollment: 20
Study Start Date: February 2006
Estimated Study Completion Date: October 2011
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   5 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria
  • 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.

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00288938

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00288938     History of Changes
Obsolete Identifiers: NCT00335530
Other Study ID Numbers: 060060, 06-C-0060
Study First Received: February 8, 2006
Last Updated: November 1, 2011
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Suspicious mole
Congenital Nevus
Skin Cancer
Moles
Pigmented lesion
LCMN

Additional relevant MeSH terms:
Melanoma
Nevus
Nevus, Epithelioid and Spindle Cell
Nevus, Pigmented
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Neuroectodermal Tumors
Neuroendocrine Tumors
Nevi and Melanomas
Nevus, Spindle Cell

ClinicalTrials.gov processed this record on October 23, 2014