Clinical trial · Observational
Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Melanoma | Melanoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Genomic profile
- timeFrame
- At participant enrollment
- description
- 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.
Secondary outcomes (1)
- measure
- Overall Survival (OS)
- timeFrame
- Up to 10 years following on-study date
- description
- OS will be calculated as time from date of diagnosis to date of death or date of last follow-up up to 10 years. OS will be estimated by Kaplan-Meier method.
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available