NCT02775643 · St. Jude Children's Research Hospital
Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
What this study is about
This is an observational, non-therapeutic study to collect clinical and molecular information of pediatric patients with childhood melanocytic lesions.
View original scientific description
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.
Primary outcome measures
Genomic profile
Time frame: At participant enrollment
Pathology/molecular samples may be available in pathology banking system or may be obtained at the same time as specimens are taken from individual consenting participants (time varies according to specific therapeutic protocol). A comprehensive molecular analysis of tumor samples either from paraffin embedded and/or frozen tissue from patients will be performed. Summary statistics will be calculated for the pathology/molecular data.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Memphis, Tennessee
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 10, 2025 · Source of record for eligibility and locations