Molecular Analysis of Childhood and Adolescent Melanocytic Lesions
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|ClinicalTrials.gov Identifier: NCT02775643|
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : October 15, 2019
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.
|Condition or disease|
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).
|Study Type :||Observational [Patient Registry]|
|Estimated Enrollment :||500 participants|
|Target Follow-Up Duration:||10 Years|
|Official Title:||Molecular Analysis of Childhood and Adolescent Melanocytic Lesions|
|Actual Study Start Date :||May 31, 2016|
|Estimated Primary Completion Date :||May 31, 2031|
|Estimated Study Completion Date :||May 31, 2041|
- Genomic profile [ Time Frame: At participant enrollment ]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.
- Overall Survival (OS) [ Time Frame: Up to 10 years following on-study date ]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.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775643
|Contact: Alberto Pappo, MDfirstname.lastname@example.org|
|United States, Tennessee|
|St. Jude Children's Research Hospital||Recruiting|
|Memphis, Tennessee, United States, 38105|
|Contact: Alberto Pappo, MD 866-278-5833 email@example.com|
|Principal Investigator: Alberto Pappo, MD|
|Principal Investigator:||Alberto Pappo, MD||St. Jude Children's Research Hospital|