Recruiting

Observational Study

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT02775643

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Melanoma

Study ID

NCT02775643

Start date

May 31, 2016

Status verified date

Nov, 2025

Completion date

May 31, 2041

Anticipated

Primary completion date

May 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Genomic profile [ Time Frame: At participant enrollment ]

Central Contacts and Locations

Central contacts

Alberto Pappo, MD

866-278-5835referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38105

Contacts

Alberto Pappo, MD

866-278-5833referralinfo@stjude.org

Principal Investigator:

Alberto Pappo, MD

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Nov 10, 2025

Last verified

Nov, 2025

Keywords

  • Melanoma
  • Spitzoid Melanoma
  • Congenital Melanoma
  • Melanoma Arising in Giant Nevi
  • Melanocytic lesions with indeterminate biological behavior
  • Pigment synthesizing melanomas

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2025-11-10.