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Brain Slice Explants to Predict Drug Response in Brain Tumors

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05978557
Enrollment
50
Registered
2023-08-07
Start date
2023-07-27
Completion date
2028-03-01
Last updated
2026-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Central Nervous System Tumor

Keywords

patient-derived explant, tissue

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.

Interventions

OTHERBiospecimen collection

Biospecimen will be collected during surgery.

Sponsors

UNC Lineberger Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Proportion of specimens yielding scoresUp to 28 daysThe 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

MeasureTime frameDescription
The scalability of evaluable specimensUp to 28 daysThe percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.

Countries

United States

Contacts

CONTACTDevin McCarthy
devin_mccarthy@med.unc.edu919-966-7654
CONTACTLuz Cuaboy
luz_cuaboy@med.unc.edu
PRINCIPAL_INVESTIGATORAndrew B Satterlee, PhD

UNC Lineberger Comprehensive Cancer Center

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 5, 2026