Status:
UNKNOWN
A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED
Lead Sponsor:
Doo-Sik Kong
Conditions:
Glioblastoma
Eligibility:
All Genders
19-90 years
Brief Summary
This is an exploratory study to evaluate the clinical feasibility of medical deivce 'AVATAMED' for predicting the clinical response to TMZ (temozolomide) in glioblasotma patients.
Detailed Description
Glioblastoma patients who would take TMZ treatment will be screened for in vitro drug screening experiment. Patients whose tumor specimen pass the drug screening process will be finally enrolled. Act...
Eligibility Criteria
Inclusion
- written informed consent
- histologically confirmed glioblastoma patients who will take TMZ treatment
- KPS \>70
- adequte end-organ function
- prior major surgery \> 4 weeks (prior minor surgery \> 1weeks)
- prior standard concurrent chemo-radiation therapy \> 4 weeks
- prior radiation therapy (including stereotactic radiosurgery) \> 12 weeks
Exclusion
- contraindication to TMZ
- prior anti-cancer therapy except standard of care (\*standard of care includes surgery, Stupp regimen, and radiotherapy)
- uncontrolled systemic medical illness
- pregnancy
Key Trial Info
Start Date :
July 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
January 1 2022
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04313842
Start Date
July 1 2019
End Date
January 1 2022
Last Update
March 18 2020
Active Locations (1)
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1
Samsung Medical Center
Seoul, South Korea, 06351