Brain Slice Explants to Predict Drug Response in Brain Tumors

Recruiting

• Conditions: Central Nervous System Tumor

• Registration Number: NCT05978557
• Lead Sponsor: UNC Lineberger Comprehensive Cancer Center

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 available

Study Timeline

• Study Start: 2023-07-27
• Study First Submitted: 2023-07-28
• Study First Submitted QC: 2023-07-28
• Study First Posted: 2023-08-07
• Status Verified: 2024-08
• Last Update Submitted: 2024-08-19
• Last Update Posted: 2024-08-20
• Primary Completion: 2028-03-01
• Study Completion: 2028-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of specimens yielding scores	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 Outcome Measures

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

Trial Locations

Locations (1)

UNC Lineberger Comprehensive Cancer Center; 🇺🇸 Chapel Hill, North Carolina, United States