Molecular Analysis of Childhood and Adolescent Melanocytic Lesions

Melanoma Clinical Trial

Official title:

Molecular Analysis of Childhood and Adolescent Melanocytic Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02775643
• Other study ID #: MACMEL
• Status: Recruiting
• Start date: May 31, 2016
• Est. completion date: May 31, 2041

Study information

• Verified date: August 2023
• Source: St. Jude Children's Research Hospital
• Contact: Alberto Pappo, MD
• Phone: 866-278-5835
• Email: referralinfo[@]stjude.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

Investigators will study the DNA and RNA in tumor cells and blood cells to look for changes that may be related to the development of the tumor, as well as changes that may influence how the tumor responds or doesn't respond to treatment. Normal blood cells will be studied to compare to the tumor cells. Investigators will also look at basic information about the treatment received and how the tumor responds, i.e. what kind of chemotherapy, surgery, radiation treatment, or other therapy the participant received, whether they had serious side effects, and how well the tumor responded to the treatment.

As part of regular medical care, tumor will be obtained to determine the type of cancer. For participants who consent to this study, leftover tumor tissue not needed for diagnosis or regular medical care will be studied at St. Jude Children's Research Hospital where scientists will look for changes in the genes of the tumor cells. No additional surgeries or procedures are needed for this study. A small amount of blood (2-3 tablespoons) will be collected and analyzed to determine if the genetic changes in the tumor cells are also found in the blood cells. Small children (<42 lbs.) will have a smaller amount drawn (1-2 tablespoons).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: May 31, 2041
• Est. primary completion date: May 31, 2031
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Melanoma

Locations

Country	Name	City	State
United States	St. Jude Children's Research Hospital	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
St. Jude Children's Research Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Overall Survival (OS)	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.	Up to 10 years following on-study date

External Links

•   Clinical Trials Open at St. Jude
•   St. Jude Children's Research Hospital