Molecular Analysis of Childhood and Adolescent Melanocytic Lesions

  • STATUS
    Recruiting
  • End date
    May 31, 2041
  • participants needed
    500
  • sponsor
    St. Jude Children's Research Hospital
Updated on 4 October 2022
cancer
nevus
immunomodulators
immunologic adjuvant

Summary

This is an observational, non-therapeutic study to collect clinical and molecular information of pediatric patients with childhood melanocytic lesions.

PRIMARY OBJECTIVE: To perform a comprehensive molecular analysis of samples either from paraffin embedded and/or frozen tissue from patients with pediatric melanocytic lesions (including melanoma, spitzoid melanoma, congenital melanoma, melanoma arising in giant nevi).

SECONDARY OBJECTIVE: To collect minimal information on patients treated with adjuvant or systemic therapies according to National Comprehensive Cancer Network (NCCN) guidelines.

Description

Investigators will study the DNA and RNA in tumor cells and blood cells to look for changes that may be related to the development of the tumor, as well as changes that may influence how the tumor responds or doesn't respond to treatment. Normal blood cells will be studied to compare to the tumor cells. Investigators will also look at basic information about the treatment received and how the tumor responds, i.e. what kind of chemotherapy, surgery, radiation treatment, or other therapy the participant received, whether they had serious side effects, and how well the tumor responded to the treatment.

As part of regular medical care, tumor will be obtained to determine the type of cancer. For participants who consent to this study, leftover tumor tissue not needed for diagnosis or regular medical care will be studied at St. Jude Children's Research Hospital where scientists will look for changes in the genes of the tumor cells. No additional surgeries or procedures are needed for this study. A small amount of blood (2-3 tablespoons) will be collected and analyzed to determine if the genetic changes in the tumor cells are also found in the blood cells. Small children (<42 lbs.) will have a smaller amount drawn (1-2 tablespoons).

Details
Condition Melanoma
Clinical Study IdentifierNCT02775643
SponsorSt. Jude Children's Research Hospital
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Participant has a 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)
Participant was <19 years of age at the time of diagnosis
Tissue is available for biologic studies
Participant has been enrolled on the TBANK protocol at SJCRH, or will be enrolled before any research tests are performed on their biological materials

Exclusion Criteria

Ocular melanoma
Inability or unwillingness of research participant or legal guardian to consent
Histologic diagnosis other than melanocytic lesion described in 3.1.1
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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