A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-01-01

Brief Summary

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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.

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Detailed Description

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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.

Actual clinical response to TMZ treatment will be compared to drug screening results derived from AVATAMED, a medical software device to predict the drug response based on in vitro assay using patient-derived tumor cells.

Conditions

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Glioblastoma

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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AVATAMED

tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. written informed consent
2. histologically confirmed glioblastoma patients who will take TMZ treatment
3. KPS \>70
4. adequte end-organ function
5. prior major surgery \> 4 weeks (prior minor surgery \> 1weeks)
6. prior standard concurrent chemo-radiation therapy \> 4 weeks
7. prior radiation therapy (including stereotactic radiosurgery) \> 12 weeks

Exclusion Criteria

1. contraindication to TMZ
2. prior anti-cancer therapy except standard of care (\*standard of care includes surgery, Stupp regimen, and radiotherapy)
3. uncontrolled systemic medical illness
4. pregnancy

Minimum Eligible Age

19 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No