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Trial Title:
Brain Slice Explants to Predict Drug Response in Brain Tumors
NCT ID:
NCT05978557
Condition:
Central Nervous System Tumor
Conditions: Official terms:
Nervous System Neoplasms
Central Nervous System Neoplasms
Conditions: Keywords:
patient-derived explant
tissue
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Biospecimen collection
Description:
Biospecimen will be collected during surgery.
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.
Criteria for eligibility:
Study pop:
Pediatric and adult subjects having low- or high-grade central nervous system tumors
resected.
Sampling method:
Non-Probability Sample
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 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.
Gender:
All
Minimum age:
N/A
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
UNC Lineberger Comprehensive Cancer Center
Address:
City:
Chapel Hill
Zip:
27516
Country:
United States
Status:
Recruiting
Contact:
Last name:
Andrew B Satterlee, PhD
Email:
satterle@email.unc.edu
Contact backup:
Last name:
Devin McCarthy
Email:
devin_mccarthy@med.unc.edu
Start date:
July 27, 2023
Completion date:
March 1, 2028
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05978557
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
