Study Stopped
Enrollment and/or interactions/interventions were halted prematurely due to loss of funding.
Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
2 other identifiers
observational
6
1 country
1
Brief Summary
Glioblastomas (GBM) demonstrate in vivo genetic and histologic heterogeneity that can be non-invasively identified using imaging phenotypes that identify regionally distinct areas of tumor with genetic alterations that drive tumor resistance pathways. The researchers propose a unique approach to assess initial GBM heterogeneity by performing histological and genomic analysis of biopsies targeted by advanced MRI before treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jul 2018
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2017
CompletedFirst Posted
Study publicly available on registry
September 19, 2017
CompletedStudy Start
First participant enrolled
July 5, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
March 23, 2020
CompletedJuly 1, 2025
June 1, 2025
1.7 years
September 15, 2017
June 26, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Identify candidate genes with differential expression in therapy-resistant imaging subvolumes
At time of surgery
Interventions
Stereotactic biopsies will be performed prior to resection.
Eligibility Criteria
Patients with glioblastoma eligible for surgical biopsy and/or resection
You may qualify if:
- Suspected newly diagnosed or recurrent supratentorial glioblastoma eligible for surgical biopsy and/or resection
- Patients must be 18 years of age or older
- Study-specific informed consent approved for this purpose by the IRB of the University of Michigan
You may not qualify if:
- Patients unable to undergo MRI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Michigan
Ann Arbor, Michigan, 48109, United States
Biospecimen
Specimens will be analyzed with next generation sequencing (NGS). The primary objective is to identify candidate genes with differential expression in therapy-resistant imaging subvolumes.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michelle Kim, M.D.
University of Michigan
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2017
First Posted
September 19, 2017
Study Start
July 5, 2018
Primary Completion
March 23, 2020
Study Completion
March 23, 2020
Last Updated
July 1, 2025
Record last verified: 2025-06