Analysis of childhood and adolescent melanocytic lesions
Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
This study is looking to see how genetic changes in kids and teens with skin lesions, including melanoma, affect their treatment and outcomes, using information collected during their regular medical care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 500 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | St. Jude Children's Research Hospital Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Memphis, Tennessee) |
| Trial ID | NCT02775643 on ClinicalTrials.gov |
What this trial studies
This observational study aims to collect clinical and molecular information from pediatric patients diagnosed with melanocytic lesions, including various types of melanoma. Researchers will analyze DNA and RNA from tumor and blood cells to identify genetic changes associated with tumor development and treatment response. The study will also gather information on treatments received and their effectiveness, without requiring additional procedures beyond standard medical care. Tumor samples will be obtained as part of routine diagnosis, and a small amount of blood will be collected for analysis.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under 19 years old with a suspected or confirmed diagnosis of specific melanocytic lesions.
Not a fit: Patients with ocular melanoma or those unwilling to consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance understanding of pediatric melanoma and improve treatment strategies for affected patients.
How similar studies have performed: Other studies have shown success in analyzing genetic changes in tumors, making this approach promising but still focused on a specific pediatric population.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Memphis, Tennessee
- St. Jude Children's Research Hospital — Memphis, Tennessee, United States (Recruiting)
Study contacts
- Principal investigator: Alberto Pappo, MD — St. Jude Children's Research Hospital
- Study coordinator: Alberto Pappo, MD
- Email: referralinfo@stjude.org
- Phone: 866-278-5835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.