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NCT04313842 Clinical Trial

A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

Glioblastoma Clinical Trial

Official title:
A Clinical Study to Explore the Feasibility of AVATAMED in Predicting the Cilnical Response to Temozolomide in Glioblastoma Patients, a Single-center, Prospective Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT04313842
Other study ID # 2018-12-071
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date January 1, 2022

Study information
Verified date March 2020
Source Samsung Medical Center
Contact Doo-sik Kong, MD PhD
Phone 82-2-6182-5036
Email doosik.kong@samsung.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

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.

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.

Recruitment information / eligibility
Status Recruiting
Enrollment 40
Est. completion date January 1, 2022
Est. primary completion date June 1, 2021
Accepts healthy volunteers No
Gender All
Age group 19 Years to 90 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• 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

Locations
Country Name City State
Korea, Republic of Samsung Medical Center Seoul

Sponsors (1)
Lead Sponsor Collaborator
Doo-Sik Kong

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 6 month PFS rate the fraction of patients without disease progression at 6 months after the TMZ treatment 6 month
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