Drug Response Testing and Repurposing Using Glioblastoma Organoid
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorChungnam National University Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
primary or recurrent glioblastoma
patients treated with standard treatment including surgery and temozolomide based chemoradiation therapy
sufficient tumor sample is available for organoid culture
Disqualifiers
patients who are not underwent concurrent chemoradiation therapy (CCRT) following surgery
failed to obtain MRI scan after CCRT
patients refusal
Trial population
patients diagnosed with primary or recurrent glioblastoma
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Organoid-based drug sensitivity test
Other interventionThe 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.
Treatment groups
150 Participants
are divided into 1 treatment groupGroup A: glioblastoma1 intervention
Trial outcomes
Primary outcomes
1
progression-free survival
Radiologic progression time following the RANO 2.0 criteria
Time frame
12 months after surgerySecondary outcomes
1
overall survival
patient survival time
Time frame
18 months after surgeryLocations
1Map coordinates are unavailable for these locations. Locations are shown below instead.
Chungnam National University HospitalRecruiting35015, Daejeon, Chungcheongnam-doSouth Korea
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Chungnam National University Hospital
Lead sponsor
Korea Advanced Institute of Science and Technology
Collaborator
Keimyung University Dongsan Medical Center
Collaborator
Soonchunhyang University Hospital
Collaborator
Dong-A University Hospital
Collaborator
Yeungnam University Hospital
Collaborator
Source ClinicalTrials.gov