Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
1 other identifier
observational
500
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2016
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 12, 2016
CompletedFirst Posted
Study publicly available on registry
May 17, 2016
CompletedStudy Start
First participant enrolled
May 31, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2041
November 10, 2025
November 1, 2025
15 years
May 12, 2016
November 6, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Genomic profile
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.
At participant enrollment
Secondary Outcomes (1)
Overall Survival (OS)
Up to 10 years following on-study date
Eligibility Criteria
Participants who meet inclusion criteria and consent to enrollment on the study at St. Jude Children's Research Hospital (SJCRH).
You may qualify if:
- 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.
You may not qualify if:
- Ocular melanoma
- Inability or unwillingness of research participant or legal guardian to consent.
- Histologic diagnosis other than melanocytic lesion described in 3.1.1.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St. Jude Children's Research Hospital
Memphis, Tennessee, 38105, United States
Related Links
Biospecimen
Melanoma tumor tissue and normal blood cells.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Alberto Pappo, MD
St. Jude Children's Research Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 10 Years
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 12, 2016
First Posted
May 17, 2016
Study Start
May 31, 2016
Primary Completion (Estimated)
May 31, 2031
Study Completion (Estimated)
May 31, 2041
Last Updated
November 10, 2025
Record last verified: 2025-11