Brain Slice Explants to Predict Drug Response in Brain Tu... | NCT05978557

Studies
Brain Slice Explants to Predict Drug Response in Brain Tumors

NCT05978557

Sponsor

UNC Lineberger Comprehensive Cancer Center

Status

Recruiting

Last Update Posted

Aug 29, 2025Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Central Nervous System Tumor

Interventions

Biospecimen collection

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2025

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 27, 2023Actual

Primary Completion Date

Mar 1, 2028Estimated

Completion Date

Mar 1, 2028Estimated

First Submitted Date

Jul 28, 2023

First Submission Date that Met QC Criteria

Jul 28, 2023

First Posted Date

Aug 7, 2023Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2025

Last Update Posted Date

Aug 29, 2025Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This biospecimen collection study will evaluate the feasibility of engrafting and testing resected Central nervous system (CNS) tumors tumor tissue ex vivo to estimate drug response, in pediatric and adult subjects. CNS tumors display remarkable heterogeneity and unfortunately there are no reliable precision oncology platforms that can identify the most effective therapy for each patient. Recent work has demonstrated the success of functional precision oncology platforms using patient-derived explant (PDE) at predicting drug response in various cancers. Since PDEs maintain important aspects of tumor heterogeneity they may prove effective as functional models for CNS tumors. The purpose of this study is to explore the feasibility of using a novel PDE platform to generate drug sensitivity scores from patients with central nervous system tumors in Pediatric and adult subjects having low- or high-grade CNS tumors resected. The secondary objective is to estimate the proportion of successfully scaled PDEs generated per given tumor size.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Estimated

Name	Type	Description	Arm Group Labels	Other Names
Biospecimen collection	Other	Biospecimen will be collected during surgery.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Proportion of specimens yielding scores	The proportion of evaluable specimens yielding patient-derived explant (PDE) drug sensitivity scores. Specimens will be collected during surgery for tumor resection. Excised specimens will be processed to generate PDE-based functional drug screening models. A panel of therapeutics will be chosen for each specimen according to pre-set criteria determined.	Up to 28 days

Secondary Outcomes

Measure	Description	Time Frame
The scalability of evaluable specimens	The percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.	Up to 28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Inclusion Criteria:

Written informed consent obtained to participate in the study and HIPAA authorization for the release of personal health information or written assent and parental consent for pediatric subjects or surrogate consent provided by the subject's legally authorized guardians.
A diagnosis of a tumor residing in the central nervous system with surgery plan to have surgical resection.
The subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.

Exclusion Criteria:

All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:

Any serious medical or psychiatric disorder that would interfere with the subject's ability to give informed consent.
Incarcerated individuals.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Pediatric and adult subjects having low- or high-grade central nervous system tumors resected.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Devin McCarthy	Contact	919-966-7654		devin_mccarthy@med.unc.edu
Luz Cuaboy	Contact			luz_cuaboy@med.unc.edu

Overall Officials

Name	Affiliation	Role
Andrew B Satterlee, PhD	UNC Lineberger Comprehensive Cancer Center	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UNC Lineberger Comprehensive Cancer Center	Recruiting	Chapel Hill	North Carolina	27516	United States

Label	URL
University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials	View source

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D016543	Central Nervous System Neoplasms

Ancestor Terms

ID	Term
D009423	Nervous System Neoplasms
D009371	Neoplasms by Site
D009369	Neoplasms
D009422	Nervous System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided