GliomaNCT04122521
Radiogenomic and Prognosis Analysis in Glioma
An observational study of Glioma, run by Asan Medical Center at 1 site in South Korea.
Trial summary
This study aims to evaluate whether MRI can be used to predict genomics and prognosis in glioma. Given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma
- What is being tested?
- MRI
- How many people
- 62 participants
- Where
- 1 siteSouth Korea
- Study dates
- 12 Jan 2020to Feb 2021
- 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 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients of tertiary hospital center
Who may be able to join
- Patients suspected of glioma undergoing MRI examination prior to surgery
- MRI including advanced imaging such as cerebral blood volume, apparent diffusion coefficient and amide proton transfer imaging
- Signed informed consent
Who cannot join
- Pathologic confirmation as tumors other than glioma
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
Trial locations and contacts
1 site in 1 country.
Min Jae Kim, MD contact
About this study
Official title: Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma
This study aims to evaluate whether MRI can be used to predict genomics and prognosis in glioma. Given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. To be able to predict genomics and prognosis based on imaging alone will prove useful in patients with involvement of glioma in delicate areas of the brain and better reflect tumor and molecular heterogeneity.
Read the detailed description
Previous studies have proposed certain imaging characteristics correlating with genetic, molecular and expression patterns. Advanced imaging provides additional clues but no studies have examined its added value particularly in a prospective setting. The investigator's aim to evaluate preoperative MRI for patients suspected of glioma to predict IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status using imaging characteristics such as margin, patterns of contrast enhancement and edema as well as diffusion and perfusion characteristics. This will be confirmed pathologically and further correlated with patients' long term outcome.
- Conditions
- Glioma
- Being tested
- MRI
- Medical subject headings
- Glioma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MRIDiagnostic test
MRI
| Study group | Role | What they receive |
|---|---|---|
| Glioma | Patients suspected of glioma Receives: Diagnostic Test: MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to progression
The response was determined by a modification of the response assessment in neuro-oncology (RANO) criteria that combined the image assessment, neurologic evaluation and assessment of steroid use.
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status
Proportion of positive IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation in percentage (%)
Measured: 2 months
Progression free survival
Estimated probable duration of life without disease progression, from on-study date to earlier progression date or date of death from any cause, using the Kaplan-Meier method with censoring. The response was determined by a modification of the RANO criteria that combined the image assessment, neurologic evaluation and assessment of steroid use.
Measured: Through study completion, an average of 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2019
- Study start12 Jan 2020
- Primary completionFeb 2021 (estimated)
- Study completionFeb 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GliomaStudies of the same condition, open and under way.
- More trials run by Asan Medical CenterThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Asan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ho Sung Kim, Asan Medical Center
- Investigators
- Ho Sung Kim, MD PhD, Principal investigator, Asan Medical CenterJi Eun Park, MD PhD, Study director, Asan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04122521
- Sponsor's protocol ID
- AsanMCHSKim_03
- Status last verified
- Feb 2020
- First submitted
- 7 Oct 2019
- Last updated
- 7 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma
- ClinicalTrials.gov ID
- NCT04122521
- Acronym / sponsor ID
- AsanMCHSKim_03
- Conditions
- Glioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Asan Medical CenterUniversity, hospital or other
- Study start
- 12 Jan 2020 (actual)
- Primary completion
- Feb 2021 (estimated)
- Study completion
- Feb 2021 (estimated)
- First posted
- 10 Oct 2019 (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 study aims to evaluate whether MRI can be used to predict genomics and prognosis in glioma. Given the profound prognostic significance of genetic mutations seen in glioma, there have been increasing attempts to correlate imaging characteristics with genetic, mutational and expression patterns. To be able to predict genomics and prognosis based on imaging alone will prove useful in patients with involvement of glioma in delicate areas of the brain and better reflect tumor and molecular heterogeneity.
Detailed description
Previous studies have proposed certain imaging characteristics correlating with genetic, molecular and expression patterns. Advanced imaging provides additional clues but no studies have examined its added value particularly in a prospective setting. The investigator's aim to evaluate preoperative MRI for patients suspected of glioma to predict IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status using imaging characteristics such as margin, patterns of contrast enhancement and edema as well as diffusion and perfusion characteristics. This will be confirmed pathologically and further correlated with patients' long term outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glioma | – | Diagnostic Test: MRIPatients suspected of glioma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients of tertiary hospital center
Key inclusion criteria (3 listed)
- Patients suspected of glioma undergoing MRI examination prior to surgery
- MRI including advanced imaging such as cerebral blood volume, apparent diffusion coefficient and amide proton transfer imaging
- Signed informed consent
Key exclusion criteria (3 listed)
- Pathologic confirmation as tumors other than glioma
- Patients who have any type of bioimplant activated by mechanical, electronic, or magnetic means (e.g., cochlear implants, pacemakers, neurostimulators, biostimulates, electronic infusion pumps, etc), because such devices may be displaced or malfunction
- Patients who are pregnant or breast feeding; urine pregnancy test will be performed on women of child bearing potential
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 |
|---|---|---|
| MRIMRI | Diagnostic test | Glioma |
Primary outcome
Time to progression
Time frame: Through study completion, an average of 2 years
The response was determined by a modification of the response assessment in neuro-oncology (RANO) criteria that combined the image assessment, neurologic evaluation and assessment of steroid use.
2 secondary outcomes
Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status
Time frame: 2 months
Progression free survival
Time frame: Through study completion, an average of 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2020.
- Individual participant dataSharing planned: Yes
Related trials for Glioma
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Active, not recruitingPhase 3
EF-41/KEYNOTE D58: Phase 3 Study of Optune Concomitant With Temozolomide Plus Pembrolizumab in Newly Diagnosed Glioblastoma
Glioblastoma
RecruitingPhase 3
A Study of the Drugs Selumetinib vs. Carboplatin and Vincristine in Patients With Low-Grade Glioma
Low Grade Astrocytoma, Low Grade Glioma
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RecruitingPhase 1/2
Testing the Addition of an Anti-cancer Drug, Selinexor, to the Usual Chemotherapy Treatment (Temozolomide) for Brain Tumors That Have Returned After Previous Treatment
Recurrent Glioblastoma, IDH-Wildtype, Recurrent MGMT-Methylated Glioblastoma
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.
Min Jae Kim, MD contact
Ho Sung Kim, MD PhD principal investigator
Asan Medical Center
Ji Eun Park, MD PhD study director
Asan Medical Center
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 Glioma, run by Asan Medical Center 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 3 inclusion and 3 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 7 Feb 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 Ji Eun Park, MD PhD (+82 2 3010 1505, jieunp@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to progression (time frame: Through study completion, an average of 2 years). 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 7 Feb 2020.