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Adult GliomaNCT02619890

Brain Glioma Registry Combining Clinical and Imaging Information

An observational study of Adult Glioma, run by Asan Medical Center at 1 site in South Korea.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This registry aims to collect clinical and radiologic information including detailed clinical, conventional MR and advanced MR imaging data of patients with brain gliomas. Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging (dynamic susceptibility contrast, arterial spin labeling… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Adult Glioma
What is being tested?
Brain Glioma Registry
Type of treatment
Injection or infusion
How many people
9,000 participants
Where
1 siteSouth Korea
Study dates
Sep 2015to Dec 2040
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

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
  • No healthy volunteers
  • Adult, Older adult

Study population: Patients of tertiary hospital center

Who may be able to join

  • Patients must have radiologically and histologically confirmed diagnosis of Brain Glioma
  • Life expectancy of greater than 3 months
  • Must receive a first- or second-line therapy
  • Signed informed consent

Who cannot join

  • No brain gliomas
  • 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. Contact the study team or a site near you to ask about taking part.

Ho Sung Kim, M.D.,Ph.D. contact

+82230105682

radhskim@gmail.com

Ji Eun Park, M.D. contact

+82230101505

jieunp@gmail.com

South Korea1 site, 1 recruiting

  • Asan Medical Center

    Seoul

    Recruiting

Other trials in South Korea

About this study

Official title: Registry Describing Clinical Information, Conventional, and Advanced Magnetic Resonance Imaging Information of Patients With Brain Glioma

This registry aims to collect clinical and radiologic information including detailed clinical, conventional MR and advanced MR imaging data of patients with brain gliomas. Advanced MR imaging may include diffusion-weighted imaging, perfusion-weighted imaging (dynamic susceptibility contrast, arterial spin labeling, dynamic contrast enhancement), and chemical exchange saturation transfer (CEST) imaging. This registry will describe course of disease and long-term outcomes of brain gliomas.

Read the detailed description

Though the cure for brain glioma- from low grade to glioblastoma- is yet to be found, seeking for curable treatment option is actively developing. Multimodal advanced MR imaging (contrast-enhanced T1 weighted imaging, diffusion-weighted imaging, chemical exchange saturation transfer imaging, and perfusion imaging) on 3 Tesla have shown potential in patients with glioma to monitor treatment response with quantitative assessment. To find suitable imaging biomarker for treatment response, assessing clinical and radiologic outcome for long-term is essential. The creation of a registry for brain glioma in long-term follow up provides an overview of the clinical, relevant treatment standards, advanced MR imaging information, and survival data of patients and thus create opportunities for imaging biomarker research.

Conditions
Adult Glioma
Being tested
Brain Glioma Registry
Keywords
Adult Glioma, MRI
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Brain Glioma RegistryOther

Study groups in NCT02619890
Study groupRoleWhat they receive
Patients with glioma requiring treatmentPatients with glioma requiring treatment, who undergo 3-Tesla magnetic resonance imaging to measure tumor protein content (using CEST-MRI), cellularity (using DW-MRI), and perfusion (using DCE-MRI and DSC-MRI with IV administration of gadolinium-containing contrast agent
Receives: Other: Brain Glioma Registry

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Documentation of clinical information (demographics and Karnofsky performance score)

    Measured: 5 years per patient

  2. Documentation of treatment

    Measured: 5 years per patient

  3. Documentation of radiologic information of conventional MR imaging and advanced MR imaging

    Measured: 5 years per patient

Secondary outcomes (4)

  1. Progression Free Survival (PFS)

    Estimated probable duration of life without disease progression, from on-study date to earlier of 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. Complete Response (CR) was defined as complete disappearance on MR of all enhancing tumor; Partial Response (PR) was defined as greater than or equal to 50% reduction in tumor size on MR by bi-dimensional measurement; Pseudoprogression was defined when there was a decrease or stabilization of the contrast-enhancing lesions for a minimum of six months and combined with no change in treatment/ or a increase in contrast-enhancing lesion on the first subsequent follow-up MR image, as long as it stabilized on the second follow-up and there was no need for treatment change. Responder = CR+PR+Pseudoprogression, Non-responder = Progression.

    Measured: On-study date to lesser of date of progression or date of death from any cause (assessed at 6 months)

  2. One- year survival

    Number of months from date of diagnosis to date of death

    Measured: One year

  3. Overall Survival

    Measured: 5 years

  4. Identification of Imaging biomarkers of clinical significance (prognostic)

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Dec 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2040 (estimated)
  4. Study completionDec 2040 (estimated)

Resources

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
9,000 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT02619890
Sponsor's protocol ID
AsanMCHSKim_02
Status last verified
May 2024
First submitted
30 Nov 2015
Last updated
14 May 2024
Results posted
No
Data monitoring committee
No

Publications

  • Mrugala MM, Engelhard HH, Dinh Tran D, Kew Y, Cavaliere R, Villano JL, Annenelie Bota D, Rudnick J, Love Sumrall A, Zhu JJ, Butowski N. Clinical practice experience with NovoTTF-100A system for glioblastoma: The Patient Registry Dataset (PRiDe). Semin Oncol. 2014 Oct;41 Suppl 6:S4-S13. doi: 10.1053/j.seminoncol.2014.09.010. Epub 2014 Sep 16.

    PubMed 25213869

  • Marko NF, Weil RJ, Schroeder JL, Lang FF, Suki D, Sawaya RE. Extent of resection of glioblastoma revisited: personalized survival modeling facilitates more accurate survival prediction and supports a maximum-safe-resection approach to surgery. J Clin Oncol. 2014 Mar 10;32(8):774-82. doi: 10.1200/JCO.2013.51.8886. Epub 2014 Feb 10.

    PubMed 24516010

  • Moon HH, Wongsawaeng D, Park JE, Park SY, Baek S, Kim YH, Song SW, Hong CK, Kim JH, Lee MH, Park YW, Ahn SS, Pollock JM, Barajas RF Jr, Kim HS. Maximum Resection of Noncontrast-enhanced Tumor at MRI Is a Favorable Prognostic Factor in IDH Wild-Type Glioblastoma. Radiology. 2025 May;315(2):e241393. doi: 10.1148/radiol.241393.

    PubMed 40326876

  • Park JE, Kim HS, Kim N, Park SY, Kim YH, Kim JH. Spatiotemporal Heterogeneity in Multiparametric Physiologic MRI Is Associated with Patient Outcomes in IDH-Wildtype Glioblastoma. Clin Cancer Res. 2021 Jan 1;27(1):237-245. doi: 10.1158/1078-0432.CCR-20-2156. Epub 2020 Oct 7.

    PubMed 33028594

  • Park JE, Kim HS, Park SY, Nam SJ, Chun SM, Jo Y, Kim JH. Prediction of Core Signaling Pathway by Using Diffusion- and Perfusion-based MRI Radiomics and Next-generation Sequencing in Isocitrate Dehydrogenase Wild-type Glioblastoma. Radiology. 2020 Feb;294(2):388-397. doi: 10.1148/radiol.2019190913. Epub 2019 Dec 17.

    PubMed 31845844

Questions about this trial

What is this clinical trial studying?

An observational study of Adult 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 4 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: looking for participants now, as of the sponsor's last update on 14 May 2024. 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?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Ho Sung Kim, M.D.,Ph.D. (+82230105682, radhskim@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Documentation of clinical information (demographics and Karnofsky performance score) (time frame: 5 years per patient). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02619890, which also lists 5 linked publications.

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 14 May 2024.

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