Tissue Collection for Drug Screening and Bioanalysis

Sponsor

Weill Medical College of Cornell University (Other)

Overall Status

Recruiting

CT.gov ID

NCT04852354

Collaborator

(none)

100

Enrollment

Location

108

Anticipated Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to improve upon the knowledge currently available about pediatric central nervous system (CNS) tumors by further examining tissue, blood, and saliva samples from consenting patients. Parents of patients with CNS tumor may also be asked to provide saliva samples for analysis.

Condition or Disease	Intervention/Treatment	Phase
Pediatric Central Nervous System Tumor Central Nervous System Tumor

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 the patient's 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 will then be used for drug screenings and to create patient-derived xenografts.

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Tissue Collection for Drug Screening and Bioanalysis

Actual Study Start Date :

Jul 22, 2020

Anticipated Primary Completion Date :

Jul 22, 2029

Anticipated Study Completion Date :

Jul 22, 2029

Outcome Measures

Primary Outcome Measures

Evaluating and characterizing the genetic, immunohistochemical, cellular, and molecular profiles of pediatric neoplastic lesions [Through study completion, average 1-3 years]
To develop patient-derived tissue cell lines and xenografts

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

Suspected neoplastic central nervous system (CNS) lesions
Undergoing a neurosurgical procedure to remove CNS tissue and/or tumors associated with this tissue
Tissue available in excess of that required for diagnostic or clinical purposes

May also include:

Parent of patient with CNS lesion

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Weill Cornell Medicine	New York	New York	United States	10021

Sponsors and Collaborators

Weill Medical College of Cornell University

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Weill Medical College of Cornell University

ClinicalTrials.gov Identifier:

NCT04852354

Other Study ID Numbers:

20-01021289

First Posted:

Apr 21, 2021

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nervous System Neoplasms

Central Nervous System Neoplasms

Study Results

No Results Posted as of Apr 28, 2022