Drug Response Testing and Repurposing Using Glioblastoma Organoid
NCT ID: NCT06782984
Last Updated: 2025-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
150 participants
OBSERVATIONAL
2021-08-18
2030-12-31
Brief Summary
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Detailed Description
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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
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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glioblastoma
prospectively enrolled
Organoid-based drug sensitivity test
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.
Interventions
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Organoid-based drug sensitivity test
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.
Eligibility Criteria
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Inclusion Criteria
* patients treated with standard treatment including surgery and temozolomide based chemoradiation therapy
* sufficient tumor sample is available for organoid culture
Exclusion Criteria
* failed to obtain MRI scan after CCRT
* patients refusal
ALL
No
Sponsors
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Korea Advanced Institute of Science and Technology
OTHER
Keimyung University Dongsan Medical Center
OTHER
Soonchunhyang University Hospital
OTHER
Dong-A University Hospital
OTHER
Yeungnam University Hospital
OTHER
Chungnam National University Hospital
OTHER
Responsible Party
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Kyung Hwan Kim
Assistant Professor
Principal Investigators
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Kyung Hwan Kim, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Department of Neurosurgery, Chungnam National University Hospital
Kijoon Yoon, PhD
Role: PRINCIPAL_INVESTIGATOR
Korea Advanced Institute of Science and Technology
Locations
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Chungnam National University Hospital
Daejeon, Chungcheongnam-do, South Korea
Countries
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Central Contacts
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Facility Contacts
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Kyung Hwan Kim, MD, PhD
Role: backup
Other Identifiers
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CNUH 2021-08-020-012
Identifier Type: -
Identifier Source: org_study_id
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