RECRUITING

Brain Slice Explants to Predict Drug Response in Brain Tumors

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2023-07-27
Study Completion:2028-03-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05978557

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. A diagnosis of a tumor residing in the central nervous system with surgery plan to have surgical resection.
  3. 3. The subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designer.
  1. 1. All subjects must not meet any of the following exclusion criteria prior to enrollment to participate in this study:
  2. 2. Incarcerated individuals.

Contacts and Locations

Study Contact

Devin McCarthy
CONTACT
919-966-7654
devin_mccarthy@med.unc.edu
Luz Cuaboy
CONTACT
luz_cuaboy@med.unc.edu

Principal Investigator

Andrew B Satterlee, PhD
PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center

Study Locations (Sites)

UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27516
United States

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

  • Andrew B Satterlee, PhD, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-07-27
Study Completion Date2028-03-01

Study Record Updates

Study Start Date2023-07-27
Study Completion Date2028-03-01

Terms related to this study

Keywords Provided by Researchers

  • patient-derived explant
  • tissue

Additional Relevant MeSH Terms

  • Central Nervous System Tumor