Brain Slice Explants to Predict Drug Response in Brain Tumors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Biospecimen collection.
- Who it may be relevant to
- Registry conditions: Central Nervous System Tumor. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official 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
Overview
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
- Other Biospecimen collection
Biospecimen will be collected during surgery.
Primary outcome measures
- Proportion of specimens yielding scores [Time frame: Up to 28 days]
Secondary outcome measures (1)
- The scalability of evaluable specimens [Time frame: Up to 28 days]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- UNC Lineberger Comprehensive Cancer Center — Chapel Hill
Identifiers
NCT: NCT05978557 · LCCC2212