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Status unknownNCT04313842Updated Mar 18, 2020

A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED

An observational study in Glioblastoma, sponsored by Doo-Sik Kong. Status unknown at 1 site in South Korea. Open to participants aged 19 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-03-18.

Sponsored by Doo-Sik Kong · Observational

The sponsor has not verified this record recently (last verified Mar 2020), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
40
Ages
19 Years to 90 Years
Sex
All
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Study 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.

Read the 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.

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.

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Conditions studied

  • Glioblastoma

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03

In context

Glioblastoma

1,951 studies on the registry are indexed under Glioblastoma; 457 are open to participants now.

This study's planned enrollment of 40 is below the median of 60 across 190 observational studies indexed under Glioblastoma.

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Lead sponsor

This is the only study on the registry with Doo-Sik Kong as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
19 Years to 90 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

among histologically confirmed glioblastoma patients, patients with samples which passed the QC screening process of in vitro drug screening experiment will be finally enrolled.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
40 participants (estimated)
Patient registry
No

Interventions

  • DeviceAVATAMED

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

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What researchers measure

Primary outcomes

  1. 6 month PFS rate

    the fraction of patients without disease progression at 6 months after the TMZ treatment

    Time frame: 6 month

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Study locations

1 of 1 sites recruiting
  • Samsung Medical Center
    Seoul, 06351, South Korea
    Recruiting
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 18, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04313842
Lead sponsor
Doo-Sik Kong
Responsible party
Doo-Sik Kong (Professor, Samsung Medical Center) — Sponsor-investigator
First posted
Mar 18, 2020
Start date
Jul 1, 2019
Primary completion
Jun 1, 2021 (estimated)
Completion
Jan 1, 2022 (estimated)
Last update
Mar 18, 2020

Study contacts

Doo-sik Kong, MD PhD
Contact
doosik.kong@samsung.com
82-2-6182-5036
Doo-sik Kong, MD PhD
principal investigator · Professor

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Mar 2020. You cannot join it, but the record below documents what was studied.

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