Central Nervous System TumorNCT05978557
Brain Slice Explants to Predict Drug Response in Brain Tumors
An observational study of Central Nervous System Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Central Nervous System Tumor
- What is being tested?
- Biospecimen collection
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Jul 2023to 1 Mar 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adult subjects having low- or high-grade central nervous system tumors resected.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Luz Cuaboy contact
United States1 site, 1 recruiting
- Recruiting
UNC Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, 27516
Andrew B Satterlee, PhD, satterle@email.unc.edu
Devin McCarthy, devin_mccarthy@med.unc.edu
About this study
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
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.
- Conditions
- Central Nervous System Tumor
- Being tested
- Biospecimen collection
- Keywords
- patient-derived explant, tissue
- Medical subject headings
- Central Nervous System Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biospecimen collectionOther
Biospecimen will be collected during surgery.
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of specimens yielding scores
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.
Measured: Up to 28 days
Secondary outcomes (1)
The scalability of evaluable specimens
The percentage of evaluable specimens amenable to proportionally scaled patient-derived explant (PDE) generation per specimen size will be studied.
Measured: Up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2023
- Study start27 Jul 2023
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System TumorStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Andrew B Satterlee, PhD, Principal investigator, UNC Lineberger Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05978557
- Sponsor's protocol ID
- LCCC2212
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2023
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05978557
- Acronym / sponsor ID
- LCCC2212
- Conditions
- Central Nervous System Tumor
- Keywords
- patient-derived explant, tissue
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 27 Jul 2023 (actual)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 7 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adult subjects having low- or high-grade central nervous system tumors resected.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biospecimen collectionBiospecimen will be collected during surgery. | Other | – |
Primary outcome
Proportion of specimens yielding scores
Time frame: 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.
1 secondary outcome
The scalability of evaluable specimens
Time frame: Up to 28 days
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2026.
- University of North Carolina Lineberger Comprehensive Cancer Center Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Luz Cuaboy contact
Andrew B Satterlee, PhD principal investigator
UNC Lineberger Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Central Nervous System Tumor, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devin McCarthy (919-966-7654, devin_mccarthy@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of specimens yielding scores (time frame: Up to 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Sep 2026.