Tissue Collection for Drug Screening and Bioanalysis

Central Nervous System Tumor Clinical Trial

Official title:

Tissue Collection for Drug Screening and Bioanalysis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852354
• Other study ID #: 20-01021289
• Status: Recruiting
• Start date: July 22, 2020
• Est. completion date: July 22, 2029

Study information

• Verified date: October 2023
• Source: Weill Medical College of Cornell University
• Contact: Jeffrey Greenfield, M.D.
• Phone: 212-746-2363
• Email: jpgreenf[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: July 22, 2029
• Est. primary completion date: July 22, 2029
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Central Nervous System Neoplasms
• Central Nervous System Tumor
• Nervous System Neoplasms
• Pediatric Central Nervous System Tumor

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

References & Publications (1)

Rajappa P, Cobb WS, Vartanian E, Huang Y, Daly L, Hoffman C, Zhang J, Shen B, Yanowitch R, Garg K, Cisse B, Haddock S, Huse J, Pisapia DJ, Chan TA, Lyden DC, Bromberg JF, Greenfield JP. Malignant Astrocytic Tumor Progression Potentiated by JAK-mediated Recruitment of Myeloid Cells. Clin Cancer Res. 2017 Jun 15;23(12):3109-3119. doi: 10.1158/1078-0432.CCR-16-1508. Epub 2016 Dec 30. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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