Clinical trial NCT02775643: Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
Official title: Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Melanoma
Keywords: Melanoma
Spitzoid Melanoma
Congenital Melanoma
Melanoma Arising in Giant Nevi
Melanocytic lesions with indeterminate biological behavior
Pigment synthesizing melanomas
Lead sponsor: St. Jude Children's Research Hospital
Sponsor class: OTHER
First posted: 2016-05-17
Enrollment: 500
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants who meet inclusion criteria and consent to enrollment on the study at St. Jude Children's Research Hospital (SJCRH).

Brief 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.

Detailed 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).

Eligibility criteria: 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.

Primary outcomes:
measure: Genomic profile
timeFrame: At participant enrollment
Secondary outcomes:
measure: Overall Survival (OS)
timeFrame: Up to 10 years following on-study date
Other outcomes:
Locations:
city: Memphis
country: United States
facility: St. Jude Children's Research Hospital
state: Tennessee
Study officials:
affiliation: St. Jude Children's Research Hospital
name: Alberto Pappo, MD
role: PRINCIPAL_INVESTIGATOR
References: