Brain Slice Explants to Predict Drug Response in Brain Tumors

NCT05978557 | Recruiting DMC

• 1 other identifier: LCCC2212
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Central Nervous System Tumor

Keywords

patient-derived explant; tissue

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• The scalability of evaluable specimens

  Up to 28 days

Interventions

Biospecimen collection OTHER

Biospecimen will be collected during surgery.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27516, United States

RECRUITING

Related Links

• University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials

MeSH Terms

Conditions

Central Nervous System Neoplasms

Condition Hierarchy (Ancestors)

Nervous System Neoplasms; Neoplasms by Site; Neoplasms; Nervous System Diseases

Study Officials

• Andrew B Satterlee, PhD

  UNC Lineberger Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Devin McCarthy

CONTACT

919-966-7654; devin_mccarthy@med.unc.edu

Luz Cuaboy

CONTACT

luz_cuaboy@med.unc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 7, 2023
• Study Start: July 27, 2023
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 1, 2028
• Last Updated: August 29, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)