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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
Sponsor:
Information provided by (Responsible Party):
St. Jude Children's Research Hospital

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.


Condition or disease
Melanoma

Detailed 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).


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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Melanoma




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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
Melanoma tumor tissue and normal blood cells.


Information from the National Library of Medicine

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Ages Eligible for Study:   up to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Participants who meet inclusion criteria and consent to enrollment on the study at St. Jude Children's Research Hospital (SJCRH).
Criteria

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.

Information from the National Library of Medicine

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


Contacts
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Contact: Alberto Pappo, MD 866-278-5835 referralinfo@stjude.org

Locations
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United States, Tennessee
St. Jude Children's Research Hospital Recruiting
Memphis, Tennessee, United States, 38105
Contact: Alberto Pappo, MD    866-278-5833    referralinfo@stjude.org   
Principal Investigator: Alberto Pappo, MD         
Sponsors and Collaborators
St. Jude Children's Research Hospital
Investigators
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Principal Investigator: Alberto Pappo, MD St. Jude Children's Research Hospital

Additional Information:
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Responsible Party: St. Jude Children's Research Hospital
ClinicalTrials.gov Identifier: NCT02775643     History of Changes
Other Study ID Numbers: MACMEL
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: October 15, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by St. Jude Children's Research Hospital:
Melanoma
Spitzoid Melanoma
Congenital Melanoma
Melanoma Arising in Giant Nevi
Melanocytic lesions with indeterminate biological behavior
Pigment synthesizing melanomas
Additional relevant MeSH terms:
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Melanoma
Neuroendocrine Tumors
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Nerve Tissue
Nevi and Melanomas