Clinical Trial: Natural History Study of Moles and Suspicious Melanoma

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 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.

• Detailed Summary:

  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, cell culture, and immortalization from patients with melanocytic nevi, which frequently are precursor lesions of melanoma, and primary melanoma. An important goal of this study is the acquisition of melanocytes from lager congential melanocytic nevi (LCMN) and acquired melanocytic nevi (AMN) for analysis, culture and experimental manipulation. We do not propose to acquire melanocytes from pigmented lesions suspected to represent primary melanoma because of the importance of preserving all lesional tissue required to render accurate histopathological diagnosis. However, another aim of the study is the development of enhanced clinical criteria for the diagnosis of primary cutaneous melanoma, particularly using digital epiluminescent skin microscopy, or dermoscopy, for pigmented lesion image acquisition and analysis. The close comparison of dermoscopic images of pigmented skin lesions suspicious for melanoma with lesional histopathology should be useful for expanding the knowledge base about how dermoscopy , a relatively new technique used to evaluate pigmented skin lesions, can be used to diagnose a pigmented skin lesion as benign or malignant. These detailed comparisons may also provide information about how specific visual features within the dermoscopic image field correlate with histologic features of the lesion. This information may be useful for future possible studies designed to predict accurately which portions of a primary malignant melanoma can be removed for esperimental study while retaining sufficient lesional information to guide further treatment and render an accurate prognosis.

  The study population will consist of three categories of patients: (1) infants and ch
  Sponsor: National Cancer Institute (NCI)
  

  Current Primary Outcome:
  
  

  Original Primary Outcome:
  
  

  Current Secondary Outcome:
  
  

  Original Secondary Outcome:
  
  Information By: National Institutes of Health Clinical Center (CC)
  

  Dates:
  Date Received: February 8, 2006
  Date Started: February 3, 2006
  Date Completion: October 31, 2011
  Last Updated: January 24, 2017
  Last Verified: October 31, 2011