Molecular Analysis of Childhood and Adolescent Melanocytic Lesions



Status:Recruiting
Conditions:Skin Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:Any - 18
Updated:10/17/2018
Start Date:May 31, 2016
End Date:May 31, 2041
Contact:Alberto Pappo, MD
Email:referralinfo@stjude.org
Phone:866-278-5835

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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.

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).

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.
We found this trial at
1
site
262 Danny Thomas Pl
Memphis, Tennessee 38105
(901) 495-3300
Principal Investigator: Alberto Pappo, MD
Phone: 866-278-5833
St. Jude Children's Research Hospital St. Jude is unlike any other pediatric treatment and research...
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