GlioblastomaNCT06782984
Drug Response Testing and Repurposing Using Glioblastoma Organoid
An observational study of Glioblastoma and Organoid, run by Chungnam National University Hospital at 1 site in South Korea.
Trial summary
The aim of this observational study, based on a prospectively collected cohort, is to evaluate the prognostic value of patient-derived organoids in predicting responses to conventional and repurposing drugs, including temozolomide, in patients with primary or recurrent glioblastoma. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Glioblastoma, Organoid
- What is being tested?
- Organoid-based drug sensitivity test
- How many people
- 150 participants
- Where
- 1 siteSouth Korea
- Study dates
- 18 Aug 2021to Dec 2030
- How long will I take part?
- 1 Year
- 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: patients diagnosed with primary or recurrent glioblastoma
Who may be able to join
- primary or recurrent glioblastoma
- patients treated with standard treatment including surgery and temozolomide based chemoradiation therapy
- sufficient tumor sample is available for organoid culture
Who cannot join
- patients who are not underwent concurrent chemoradiation therapy (CCRT) following surgery
- failed to obtain MRI scan after CCRT
- patients refusal
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Chungnam National University Hospital
Daejeon, Chungcheongnam-do, 35015
Kyung Hwan Kim, MD, PhD, 82-42-280-7367, nskhkim@cnuh.co.kr
Kyung Hwan Kim, MD, PhD
About this study
Official title: Patient-derived Organoids As Predictive Models for Drug Response Testing and Repurporsing in Glioblastoma Therapy
The aim of this observational study, based on a prospectively collected cohort, is to evaluate the prognostic value of patient-derived organoids in predicting responses to conventional and repurposing drugs, including temozolomide, in patients with primary or recurrent glioblastoma. The primary question is whether the patient's response to temozolomide is recapitulated in their corresponding patient-derived glioblastoma organoid (GBO). Patient drug responses are evaluated using survival data, while GBO drug responses are assessed through a drug-response testing platform utilizing cell viability assays. Additionally, this platform is used to explore the potential application of various chemotherapeutic agents.
Read the detailed description
Glioblastoma multiforme (GBM) remains a highly aggressive brain tumor with limited treatment options and a poor prognosis. Temozolomide (TMZ) is the only approved first-line therapy, but frequent resistance limits its efficacy, highlighting the urgent need for alternative treatments. Patient-derived glioblastoma organoids (GBOs) offer a promising preclinical model for personalized drug testing and therapy development.
In our previous study, we established 20 GBO lines using a serum-free protocol, preserving the histopathological and genomic features of the parental tumors. Additionally, GBO Drug Sensitivity Testing (GBO-DST) was developed to evaluate TMZ responsiveness and to screen several FDA-approved drugs, including Lazertinib and Regorafenib. The GBO-DST was successfully validated by correlating IC50 values with progression-free survival, GBO size measurement after treatment, and histopathological evaluation.
The goal of this study is to investigate whether a preclinical model using GBOs can eventually replace clinical trials. Therefore, it is necessary to collect diverse genetic information from patients in a multicenter setting, along with corresponding GBOs that recapitulate the patient tumors. Using GBO-DST, external cohort validation will be performed. Concurrently, the study aims to predict the potency of multi-kinase inhibitors or EGFR-TKIs, which are expected to show efficacy based on prior research, and compare these predictions against clinical outcomes.
This study aims to establish 100 GBO lines, targeting the enrollment of 150 patients, considering a previous success rate of 66.7% for GBO establishment. Since the study requires tumor tissue and genetic information from patients, IRB approvals from multiple institutions have been secured (including five tertiary hospitals in South Korea: Chungnam National University Hospital, Soonchunhyang University Hospital, Keimyung University Hospital, Yeungnam University Hospital, and Dong-A University Hospital). However, as this study retrospectively correlates patient clinical outcomes with GBO-DST results, it does not involve direct interventions with patients. Specifically, GBO-DST results for multiple candidate drugs will not be used to alter patients' treatment regimens.
The study collects clinical information and genetic data from patients, with clinical outcomes defined as progression-free survival and overall survival. Radiologic data will be prospectively collected to achieve these objectives.
Through this study, we aim to validate the findings of previous research by confirming that GBO-DST accurately recapitulates patients' drug responses. Furthermore, we seek to establish GBO-DST as a preclinical trial platform capable of replacing traditional clinical trials.
- Conditions
- Glioblastoma, Organoid
- Being tested
- Organoid-based drug sensitivity test
- Keywords
- organoid, glioblastoma, GBO, drug-screening
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Organoid-based drug sensitivity testOther
The intervention in this study involves utilizing glioblastoma organoids (GBOs) to perform an organoid-based drug sensitivity test (DST) and retrospectively comparing the results with clinical outcomes. Notably, no interventions will be applied to participants based on GBO-DST results; the study is limited to retrospective analysis.
The GBO-DST is conducted by performing a drug response assay with temozolomide to determine the half-maximal inhibitory concentration (IC50), which serves to classify GBOs as TMZ-sensitive or TMZ-resistant. This classification is further validated through GBO cell survival analysis.
| Study group | Role | What they receive |
|---|---|---|
| glioblastoma | prospectively enrolled Receives: Other: Organoid-based drug sensitivity test |
What is being measured
The primary outcome is the main question the study is designed to answer.
progression-free survival
Radiologic progression time following the RANO 2.0 criteria
Measured: 12 months after surgery
Secondary outcomes (1)
overall survival
patient survival time
Measured: 18 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start18 Aug 2021
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- 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
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Chungnam National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Korea Advanced Institute of Science and Technology, Keimyung University Dongsan Medical Center, Soonchunhyang University Hospital, Dong-A University Hospital, Yeungnam University Hospital
- Responsible party
- Principal investigator, Kyung Hwan Kim, Chungnam National University Hospital
- Investigators
- Kyung Hwan Kim, MD, PhD, Principal investigator, Department of Neurosurgery, Chungnam National University HospitalKijoon Yoon, PhD, Principal investigator, Korea Advanced Institute of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782984
- Sponsor's protocol ID
- CNUH 2021-08-020-012
- Status last verified
- Jan 2025
- First submitted
- 6 Jan 2025
- Last updated
- 20 Jan 2025
- 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 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-derived Organoids As Predictive Models for Drug Response Testing and Repurporsing in Glioblastoma Therapy
- ClinicalTrials.gov ID
- NCT06782984
- Acronym / sponsor ID
- CNUH 2021-08-020-012
- Conditions
- Glioblastoma, Organoid
- Keywords
- organoid, glioblastoma, GBO, drug-screening
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Chungnam National University HospitalUniversity, hospital or other
- Collaborators
- Korea Advanced Institute of Science and Technology, Keimyung University Dongsan Medical Center, Soonchunhyang University Hospital, Dong-A University Hospital, Yeungnam University Hospital
- Study start
- 18 Aug 2021 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2030 (estimated)
- First posted
- 20 Jan 2025 (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.
The aim of this observational study, based on a prospectively collected cohort, is to evaluate the prognostic value of patient-derived organoids in predicting responses to conventional and repurposing drugs, including temozolomide, in patients with primary or recurrent glioblastoma. The primary question is whether the patient's response to temozolomide is recapitulated in their corresponding patient-derived glioblastoma organoid (GBO). Patient drug responses are evaluated using survival data, while GBO drug responses are assessed through a drug-response testing platform utilizing cell viability assays. Additionally, this platform is used to explore the potential application of various chemotherapeutic agents.
Detailed description
Glioblastoma multiforme (GBM) remains a highly aggressive brain tumor with limited treatment options and a poor prognosis. Temozolomide (TMZ) is the only approved first-line therapy, but frequent resistance limits its efficacy, highlighting the urgent need for alternative treatments. Patient-derived glioblastoma organoids (GBOs) offer a promising preclinical model for personalized drug testing and therapy development.
In our previous study, we established 20 GBO lines using a serum-free protocol, preserving the histopathological and genomic features of the parental tumors. Additionally, GBO Drug Sensitivity Testing (GBO-DST) was developed to evaluate TMZ responsiveness and to screen several FDA-approved drugs, including Lazertinib and Regorafenib. The GBO-DST was successfully validated by correlating IC50 values with progression-free survival, GBO size measurement after treatment, and histopathological evaluation.
The goal of this study is to investigate whether a preclinical model using GBOs can eventually replace clinical trials. Therefore, it is necessary to collect diverse genetic information from patients in a multicenter setting, along with corresponding GBOs that recapitulate the patient tumors. Using GBO-DST, external cohort validation will be performed. Concurrently, the study aims to predict the potency of multi-kinase inhibitors or EGFR-TKIs, which are expected to show efficacy based on prior research, and compare these predictions against clinical outcomes.
This study aims to establish 100 GBO lines, targeting the enrollment of 150 patients, considering a previous success rate of 66.7% for GBO establishment. Since the study requires tumor tissue and genetic information from patients, IRB approvals from multiple institutions have been secured (including five tertiary hospitals in South Korea: Chungnam National University Hospital, Soonchunhyang University Hospital, Keimyung University Hospital, Yeungnam University Hospital, and Dong-A University Hospital). However, as this study retrospectively correlates patient clinical outcomes with GBO-DST results, it does not involve direct interventions with patients. Specifically, GBO-DST results for multiple candidate drugs will not be used to alter patients' treatment regimens.
The study collects clinical information and genetic data from patients, with clinical outcomes defined as progression-free survival and overall survival. Radiologic data will be prospectively collected to achieve these objectives.
Through this study, we aim to validate the findings of previous research by confirming that GBO-DST accurately recapitulates patients' drug responses. Furthermore, we seek to establish GBO-DST as a preclinical trial platform capable of replacing traditional clinical trials.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| glioblastoma | – | Other: Organoid-based drug sensitivity testprospectively enrolled |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients diagnosed with primary or recurrent glioblastoma
Key inclusion criteria (3 listed)
- primary or recurrent glioblastoma
- patients treated with standard treatment including surgery and temozolomide based chemoradiation therapy
- sufficient tumor sample is available for organoid culture
Key exclusion criteria (3 listed)
- patients who are not underwent concurrent chemoradiation therapy (CCRT) following surgery
- failed to obtain MRI scan after CCRT
- patients refusal
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 |
|---|---|---|
| Organoid-based drug sensitivity testThe intervention in this study involves utilizing glioblastoma organoids (GBOs) to perform an organoid-based drug sensitivity test (DST) and retrospectively comparing the results with clinical outcomes. Notably, no interventions will be applied to participants based on GBO-DST results; the study is limited to retrospective analysis. The GBO-DST is conducted by performing a drug response assay with temozolomide to determine the half-maximal inhibitory concentration (IC50), which serves to classify GBOs as TMZ-sensitive or TMZ-resistant. This classification is further validated through GBO cell survival analysis. | Other | glioblastoma |
Primary outcome
progression-free survival
Time frame: 12 months after surgery
Radiologic progression time following the RANO 2.0 criteria
1 secondary outcome
overall survival
Time frame: 18 months after surgery
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 20 Jan 2025.
- 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.
Kyung Hwan Kim, MD, PhD principal investigator
Department of Neurosurgery, Chungnam National University Hospital
Kijoon Yoon, PhD principal investigator
Korea Advanced Institute of Science and Technology
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 Glioblastoma and Organoid, run by Chungnam National University Hospital at 1 site in South Korea.
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 20 Jan 2025. 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 South Korea. 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 Kyung Hwan Kim, MD, PhD (82-42-280-7367, nskhkim@cnuh.co.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
progression-free survival (time frame: 12 months after surgery). 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 20 Jan 2025.