Tissue Collection for Drug Screening and Bioanalysis

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	N/A and Over
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT04852354
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Weill Medical College of Cornell University
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Jeffrey Greenfield, M.D.
Principal Investigator Affiliation	Weill Medical College of Cornell University
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Pediatric Central Nervous System Tumor, Central Nervous System Tumor

Additional Details

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.

Arms & Interventions

Arms

: Pediatric tumor patients undergoing neurosurgery

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

Saliva samples will be taken from parents of pediatric tumor patients meeting the inclusion criteria.

: Non-tumor patients

Blood and CSF samples will be taken from non-tumor pediatric patients meeting the inclusion criteria.

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Weill Cornell Medicine, New York, New York

Status

Recruiting

Address

Weill Cornell Medicine

New York, New York, 10021

Site Contact

Jeffrey Greenfield, M.D.

[email protected]

212-746-2363

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