GlioblastomaNCT04313842
A Explorative Study to Evaluate the Clinical Feasibility of AVATAMED
An observational study of Glioblastoma, run by Doo-Sik Kong at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 19 to 90 years
- Conditions the study is for
- Glioblastoma
- What is being tested?
- AVATAMED
- Type of treatment
- Medical device
- How many people
- 40 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Jul 2019to 1 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Samsung Medical Center
Seoul, 06351
Doo-Sik Kong, MD,Ph.D, +82-2-3410-0732, doosik.kong@samsung.com
About this study
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
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.
- Conditions
- Glioblastoma
- Being tested
- AVATAMED
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVATAMEDDevice
tumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response
What is being measured
The primary outcome is the main question the study is designed to answer.
6 month PFS rate
the fraction of patients without disease progression at 6 months after the TMZ treatment
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2020
- Study start1 Jul 2019
- Primary completion1 Jun 2021 (estimated)
- Study completion1 Jan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Doo-Sik Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Doo-Sik Kong, Samsung Medical Center
- Investigators
- Doo-sik Kong, MD PhD, Principal investigator, Professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04313842
- Sponsor's protocol ID
- 2018-12-071
- Status last verified
- Mar 2020
- First submitted
- 17 Mar 2020
- Last updated
- 18 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04313842
- Acronym / sponsor ID
- 2018-12-071
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Doo-Sik KongUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- 1 Jun 2021 (estimated)
- Study completion
- 1 Jan 2022 (estimated)
- First posted
- 18 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 19 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (7 listed)
- 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)
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVATAMEDtumor specimen will be sent for in vitro drug screening experiment and the result will be analyzed by 'AVATAMED' to predict the clinical response | Device | – |
Primary outcome
6 month PFS rate
Time frame: 6 month
the fraction of patients without disease progression at 6 months after the TMZ treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Doo-sik Kong, MD PhD principal investigator
Professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Doo-Sik Kong at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Doo-sik Kong, MD PhD (82-2-6182-5036, doosik.kong@samsung.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
6 month PFS rate (time frame: 6 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Mar 2020.