Tissue Collection for Drug Screening and Bioanalysis

October 27, 2023 updated by: Weill Medical College of Cornell University
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Estimated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10021
        • Recruiting
        • Weill Cornell Medicine
        • Contact:
        • Principal Investigator:
          • Jeffrey Greenfield, M.D.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Patients with a central nervous system tumors. Parents of patients with CNS tumors.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Weill Medical College of Cornell University

Investigators

  • Principal Investigator: Jeffrey Greenfield, M.D., Weill Medical College of Cornell University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 22, 2020

Primary Completion (Estimated)

July 22, 2029

Study Completion (Estimated)

July 22, 2029

Study Registration Dates

First Submitted

April 10, 2021

First Submitted That Met QC Criteria

April 16, 2021

First Posted (Actual)

April 21, 2021

Study Record Updates

Last Update Posted (Actual)

October 30, 2023

Last Update Submitted That Met QC Criteria

October 27, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 20-01021289

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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