Radiogenomic and Prognosis Analysis in Glioma
Prospective Observational Study of Imaging-based Prediction for Genomic Mutations and Prognosis in Glioma
1 other identifier
observational
62
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Jan 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 7, 2019
CompletedFirst Posted
Study publicly available on registry
October 10, 2019
CompletedStudy Start
First participant enrolled
January 12, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2021
CompletedFebruary 7, 2020
February 1, 2020
1.1 years
October 7, 2019
February 6, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
Through study completion, an average of 2 years
Secondary Outcomes (2)
Genomics including IDH mutation, 1p19q codeletion, MGMT methylation and EGFR mutation status
2 months
Progression free survival
Through study completion, an average of 3 years
Study Arms (1)
Glioma
Patients suspected of glioma
Interventions
Eligibility Criteria
Patients of tertiary hospital center
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Asan Medical Center
Seoul, South Korea
Biospecimen
Pathologic specimen with next generation sequencing
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ho Sung Kim, MD PhD
Asan Medical Center
- STUDY DIRECTOR
Ji Eun Park, MD PhD
Asan Medical Center
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
October 7, 2019
First Posted
October 10, 2019
Study Start
January 12, 2020
Primary Completion
February 1, 2021
Study Completion
February 1, 2021
Last Updated
February 7, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will share