Drug Response Testing and Repurposing Using Glioblastoma Organoid

NCT06782984 | Recruiting DMC

• 1 other identifier: CNUH 2021-08-020-012
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Glioblastoma; Organoid

Keywords

organoid; glioblastoma; GBO; drug-screening

Outcome Measures

Primary Outcomes (1)

• progression-free survival

  Radiologic progression time following the RANO 2.0 criteria

  12 months after surgery

Secondary Outcomes (1)

• overall survival

  18 months after surgery

Study Arms (1)

glioblastoma

prospectively enrolled

Other: Organoid-based drug sensitivity test

Interventions

Organoid-based drug sensitivity test OTHER

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.

glioblastoma

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients diagnosed with primary or recurrent glioblastoma

You may qualify if:

• primary or recurrent glioblastoma
• patients treated with standard treatment including surgery and temozolomide based chemoradiation therapy
• sufficient tumor sample is available for organoid culture

You may not qualify if:

• patients who are not underwent concurrent chemoradiation therapy (CCRT) following surgery
• failed to obtain MRI scan after CCRT
• patients refusal

Sponsors & Collaborators

• Chungnam National University Hospital: lead
• 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

Study Sites (1)

Chungnam National University Hospital

Daejeon, Chungcheongnam-do, 35015, South Korea

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

tumor tissues and organoids

MeSH Terms

Conditions

Glioblastoma

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Kyung Hwan Kim, MD, PhD

  Department of Neurosurgery, Chungnam National University Hospital

  PRINCIPAL INVESTIGATOR

• Kijoon Yoon, PhD

  Korea Advanced Institute of Science and Technology

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kyung Hwan Kim, MD, PhD

CONTACT

82-42-280-7367; nskhkim@cnuh.co.kr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 20, 2025
• Study Start: August 18, 2021
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2030
• Last Updated: January 20, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)