GlioblastomaNCT03287063
Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
An observational study of Glioblastoma, run by University of Michigan Rogel Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- What is being tested?
- Tumor Biopsy
- How many people
- 6 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jul 2018to 23 Mar 2020
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Patients with glioblastoma eligible for surgical biopsy and/or resection
Who may be able to join
- 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
Who cannot join
- Patients unable to undergo MRI
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
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.
- Conditions
- Glioblastoma
- Being tested
- Tumor Biopsy
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tumor BiopsyOther
Stereotactic biopsies will be performed prior to resection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify candidate genes with differential expression in therapy-resistant imaging subvolumes
Measured: At time of surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2017
- Study start5 Jul 2018
- Primary completion23 Mar 2020
- Study completion23 Mar 2020
Why it stopped: Enrollment and/or interactions/interventions were halted prematurely due to loss of funding.
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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan Rogel Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Kim, M.D., Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03287063
- Sponsor's protocol ID
- UMCC 2017.094
- Other IDs
- HUM00134165
- Status last verified
- Jun 2025
- First submitted
- 15 Sep 2017
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Study Using Genomic, Histologic and Radiomic Analysis to Evaluate Regional Tumor Heterogeneity in Patients Undergoing Surgery for Newly Diagnosed Glioblastoma
- ClinicalTrials.gov ID
- NCT03287063
- Acronym / sponsor ID
- UMCC 2017.094
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Enrollment and/or interactions/interventions were halted prematurely due to loss of funding.
- Enrolment
- 6 participants (actual)
- Lead sponsor
- University of Michigan Rogel Cancer CenterUniversity, hospital or other
- Study start
- 5 Jul 2018 (actual)
- Primary completion
- 23 Mar 2020 (actual)
- Study completion
- 23 Mar 2020 (actual)
- First posted
- 19 Sep 2017 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with glioblastoma eligible for surgical biopsy and/or resection
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients unable to undergo MRI
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 |
|---|---|---|
| Tumor BiopsyStereotactic biopsies will be performed prior to resection. | Other | – |
Primary outcome
Identify candidate genes with differential expression in therapy-resistant imaging subvolumes
Time frame: At time of surgery
Results and safety
The study was stopped early (reason given: Enrollment and/or interactions/interventions were halted prematurely due to loss of funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2025.
- 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.
Michelle Kim, M.D. principal investigator
University of Michigan
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 University of Michigan Rogel Cancer Center at 1 site in United States.
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 1 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: stopped early, as of the sponsor's last update on 1 Jul 2025. 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 United States. 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?
The study was stopped early (reason given: Enrollment and/or interactions/interventions were halted prematurely due to loss of funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify candidate genes with differential expression in therapy-resistant imaging subvolumes (time frame: At time of surgery). 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 1 Jul 2025.