MACMEL: A Study to Analyze Melanoma Lesions in Children and Teens

Molecular Analysis of Childhood and Adolescent Melanocytic Lesions

Category:

Solid Tumor

Diseases Treated:

Melanoma

Eligibility Overview:

  • Diagnosed with a melanoma tumor that is malignant (cancerous) or that might be cancerous, including:
    • Conventional or “adult-type” melanoma
    • Spitzoid melanoma/atypical Spitz tumor
    • Congenital melanoma
    • Melanoma arising in a giant congenital nevus
    • Melanocytic lesions with indeterminate biological behavior (e.g., pigment-synthesizing melanomas)
  • Younger than 19 years of age 
  1. Brief Summary

    Pediatric melanoma is rare, mostly affecting patients between the ages of 15 and 19 years old. Yet, the number of childhood melanoma cases continues to increase at a rate of about 2% per year.

    There are four major categories of melanocytic lesions that have unique clinical behavior and molecular profiles: spitz nevus, spitzoid melanoma, conventional melanomas, and melanoma arising in a giant congenital nevi.

    Diagnosing melanoma in younger patients can be difficult. Proper identification is vital in order to determine the most appropriate therapy.

    Primary Objective

    The main goal of the study is to perform a comprehensive molecular analysis of samples from paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions.

    Eligibility Criteria

    Inclusion Criteria include:

    • Suspected or confirmed diagnosis of a melanocytic lesion, including:
      • Conventional or “adult-type” melanoma
      • Spitzoid melanoma/atypical Spitz tumor
      • Congenital melanoma
      • Melanoma arising in a giant congenital nevus
      • Melanocytic lesions with indeterminate biological behavior (e.g., pigment-synthesizing melanomas)
    • Younger than 19 years of age at the time of diagnosis
    • Available tissue for biologic studies
    • Enrolled on TBANK, or will be enrolled, before any research tests are performed

    Exclusion Criteria include:

    • Ocular melanoma

    Study Design

    Observational, non-therapeutic

    Study Sites

    St. Jude Children’s Research Hospital
    Memphis, Tennessee

  2. About this study

    Melanoma is the most serious form of skin cancer because it can spread to other parts of the body. The most common cause of melanoma is ultraviolet (UV) radiation from the sun or tanning beds. Although the overall number of children and adolescents with melanoma is relatively small, it is the most common skin cancer in children and is increasing. Teens between the ages of 15 and 19 have the highest rates of childhood melanoma.

    There are several types of melanoma tumors, and each one has unique characteristics. Medical tests can help doctors identify these characteristics. Doctors can use that information to decide the best way to treat that specific type of tumor.

    Purpose of this observational study

    Researchers in this study want to learn more about melanoma tumors in children and adolescents. They want to understand the different types of tumors better and learn how each type responds to treatment. They also want to find out why some children and teens are more likely to develop melanoma. Doctors hope this information will help them decide which melanoma treatments are most effective. They also hope to use this information to develop new treatments for children with melanoma.

    Eligibility overview

    • Diagnosed with a melanoma tumor that is malignant (cancerous) or that might be cancerous. Tumors may include:
      • Conventional or “adult-type” melanoma
      • Spitzoid melanoma/atypical Spitz tumor
      • Congenital melanoma
      • Melanoma arising in a giant congenital nevus
      • Melanocytic lesions with indeterminate biological behavior (e.g., pigment-synthesizing melanomas)
    • Younger than 19 years of age 
  3. G4K Quick View
    Sponsor St. Jude Children’s Research Hospital 
    Clinicaltrials.gov identifier NCT02775643
    Trial start date May 2016
    Estimated enrollment 500
    Study type Observational
    Conditions Melanoma
    Ages Younger than 19 years old
    Principal investigator Alberto Pappo, MD
    Study site St. Jude Children’s Research Hospital and collaborating sites in and outside the U.S.
    For a consultation or to discuss MACMEL St. Jude Physician/Patient Referral Offic
    1-888-226-4343
    referralinfo@stjude.org

Contact

Alberto Pappo, MD

St. Jude Children’s Research Hospital
262 Danny Thomas Place
Memphis, TN 38105  USA
Voice: 1-888-226-4343 or 901-595-4055
24-Hour Emergency Access Pager: 1-800-349-4334
Email: referralinfo@stjude.org

The above information is intended to provide only a basic description about a research protocol that may be currently active at St. Jude. The details made available here may not be the most up-to-date information on protocols used by St. Jude. To receive full details about a protocol and its status and or use at St. Jude, a physician must contact St. Jude directly.