A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 19 Years - 90 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04313842
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Doo-Sik Kong
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Doo-sik Kong, MD PhD
Principal Investigator Affiliation Professor
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries Korea, Republic of
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Glioblastoma
Additional Details

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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Samsung Medical Center, Seoul, Korea, Republic of

Status

Recruiting

Address

Samsung Medical Center

Seoul, , 06351

Site Contact

Doo-Sik Kong, MD,Ph.D

doosik.kong@samsung.com

+82-2-3410-0732

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