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NCT Number: NCT05978557

Brain Slice Explants to Predict Drug Response in Brain Tumors

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.

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Key information

Conditions

Central Nervous System Tumor Central Nervous System Neoplasms Neoplasms Neoplasms by Site Nervous System Diseases Nervous System Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

UNC Lineberger Comprehensive Cancer Center

Chapel Hill, North Carolina, 27516, United States

Location status: Recruiting

Location contact

Andrew B Satterlee, PhD

CONTACT

[email protected]

Devin McCarthy

CONTACT

[email protected]

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Biospecimen Collection

Other

Biospecimen will be collected during surgery.

Primary outcomes

  1. Proportion of specimens yielding scores

    Time frame: Up to 28 days

    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.

Secondary outcomes

  1. The scalability of evaluable specimens

    Time frame: Up to 28 days

    The percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.

Study contacts

Contact information is provided by the study sponsor or research team.

Devin McCarthy

CONTACT

[email protected]

919-966-7654

Luz Cuaboy

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

UNC Lineberger Comprehensive Cancer Center

Other

Registry information

Official study title

A Feasibility Study to Determine if a Novel Patient-derived Explant Platform Can Produce Drug Sensitivity Scores Within a Clinically Relevant Time Frame in Patients With CNS Tumors

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
Aug 7, 2023
Registry last updated
Aug 29, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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