Tissue Collection for Drug Screening and Bioanalysis

Study Overview
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Brief Summary
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The purpose of this study is to improve upon the knowledge currently available about pediatric central nervous system (CNS) tumors by further examining biological samples from pediatric patients with tumors undergoing surgery.

Detailed Description
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The goal of this project is to enable the acquisition of tissue available for research with the prospect of enabling the development of new therapeutic avenues for patients diagnosed with cancer in the central nervous system. During pediatric patients' (with a CNS tumor) routine operative procedure, if extra tissue deemed unnecessary for diagnostic or clinical purposes is available, selected samples will undergo DNA and/or RNA extraction and integrity analysis, whole genome and RNA sequencing, DNA and RNA methylome analyses, proteomic analysis, immunoprofiling, and primary culturing of the tumor cells. These cultures may then be used for drug screenings and to create patient-derived xenografts, or for comparisons between tumor and non-tumor patients. Other biological samples may be collected. Additionally, saliva samples may be obtained from the parents of pediatric patients with CNS tumors, and biological samples may be collected from pediatric patients without a CNS tumor who are undergoing a neurological procedure. These samples may be used for comparison with samples from patients with CNS tumors.

Official Title
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Tissue Collection for Drug Screening and Bioanalysis

Conditions
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Pediatric Central Nervous System Tumor, Central Nervous System Tumor

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria for tumor patient: Subject has presented with a suspected neoplastic CNS lesion and is undergoing a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be removed. There must be tissue available in excess of that required by neuropathology for diagnostic purposes. Inclusion Criteria for parent of tumor patients Subject is the biological parent of a pediatric patient undergoing a neurosurgical procedure in which CNS tissue and/or tumors associated with this tissue will be removed. Inclusion Criteria for non-tumor patients Subject is under 21 years of age and is undergoing a neurosurgical procedure at WCMC. Subject has never been diagnosed with a CNS neoplasm
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pediatric tumor patients undergoing neurosurgery<br>Samples of tumor tissue, blood, CSF, saliva, skull, and dura will be taken during neurosurgery from tumor patients meeting the inclusion criteria. | |
| Parents of tumor patients<br>Saliva samples will be taken from parents of pediatric tumor patients meeting the inclusion criteria. | |
| Non-tumor patients<br>Blood and CSF samples will be taken from non-tumor pediatric patients meeting the inclusion criteria. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions | To develop patient-derived tissue cell lines and xenografts | Through study completion, average 1-3 years |