Recruiting

Drug Response

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT05978557

Conditions

Central Nervous System Tumor

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Biospecimen collection

Study Details

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

Study ID

NCT05978557

Start date

Jul 27, 2023

Status verified date

Sep, 2026

Completion date

Mar 1, 2028

Anticipated

Primary completion date

Mar 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Inclusion Criteria:

1. 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.
2. A diagnosis of a tumor residing in the central nervous system with surgery plan to have surgical resection.
3. The subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.

Exclusion Criteria:

1. 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.
2. Incarcerated individuals.

Study Design

Enrollment

50 participants

Anticipated

Interventions and Outcome Measures

Interventions

Biospecimen collection

Biospecimen will be collected during surgery.

Primary outcome measure

  • Proportion of specimens yielding scores [ Time Frame: Up to 28 days ]

Central Contacts and Locations

Central contacts

Devin McCarthy

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

Luz Cuaboy

luz_cuaboy@med.unc.edu

Locations

UNC Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27516

Contacts

Andrew B Satterlee, PhD

satterle@email.unc.edu

Devin McCarthy

devin_mccarthy@med.unc.edu

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

  • patient-derived explant
  • tissue

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-09-04.