Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeSINUENCT07111195
Feasibility of ONCOhabitats for Surgical and Treatment Planning in IDH-Wildtype Glioblastoma (SINUE)
An observational study of Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by Juan M Garcia-Gomez at 5 sites in Spain.
Trial summary
The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma. The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype
- What is being tested?
- The ONCOhabitats software for MRI-based habitat segmentation
- Type of treatment
- Medical device
- How many people
- 140 participants
- Where
- 5 sitesSpain
- Study dates
- 16 Jul 2024to Sep 2026
- 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: Adult patients (≥18 years old) with a radiological diagnosis of IDH-wildtype glioblastoma who are candidates for surgical resection. All participants must have a complete preoperative MRI study, including advanced perfusion sequences, and must provide written informed consent.
Who may be able to join
- Adults (≥18 years old) at the time of diagnosis
- Radiological diagnosis of high-grade glioma
- Candidates for surgical resection
- Availability of complete preoperative MRI studies, including:
- T1-weighted MRI (pre- and post-gadolinium)
- T2-weighted MRI
Show all 9Show fewer
- FLAIR (Fluid-Attenuated Inversion Recovery)
- T2*-weighted DSC perfusion MRI
- Signed informed consent to participate in the clinical study
Who cannot join
- Patients who do not provide informed consent
- Patients deemed inoperable
- Withdrawal criteria:
- MRI data that cannot be processed using ONCOhabitats
- Patient withdraws informed consent at any time
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Spain5 sites, 5 recruiting
- Recruiting
Hospital General Universitario Dr. Balmis
Alicante
Cristina Alenda González, +34 965913817, alenda.cris@gmail.com
- Recruiting
Hopsital Universitari Vall d'Hebron
Barcelona
Francisco Ramon Martínez Ricarte, franciscoramon.martinez@vallhebron.cat
- Recruiting
Hospital Clínico Universitario Virgen de la Arrixaca
Murcia
Belén Ferri Ñíguez, +34 606884561, belen.ferri@carm.es
- Recruiting
Hospital Universitario de Canarias
Santa Cruz de Tenerife
Julio Manuel Plata Bello, +34 922678900, jplatbel@ull.edu.es
- Recruiting
Hospital Clínic i Universitari de València
Valencia
Vicent Quilis Quesada, +34 963248164, vquilisquesada@gmail.com
About this study
Official title: Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma.
The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making.
Read more
The primary research questions are:
- Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis?
- Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy?
Participants will:
- Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection
- Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE)
- Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations
Researchers will analyze:
- Imaging biomarkers (e.g., relative cerebral blood volume, rCBV)
- Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression)
- Clinical and survival outcomes
This study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.
- Being tested
- The ONCOhabitats software for MRI-based habitat segmentation
- Keywords
- Glioblastoma, IHD-wildtype, MRI, Biomarkers, Perfussion, Tumor heterogenity, Peritumoral edema, Tumor Infiltration, Machine learning, Medical device validation, Immunosuppression, Overall survival, MGMT status
- Medical subject headings
- Glioblastoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The ONCOhabitats software for MRI-based habitat segmentationDevice
ONCOhabitats is an MRI-based software platform designed to segment IDH-wildtype glioblastomas into four biologically distinct habitats (HAT, LAT, IPE, and VPE) based on vascular heterogeneity.
In this study, the software is applied preoperatively to generate imaging biomarkers that guide surgical sampling and are assessed for their ability to predict overall survival and stratify patients accordingly.
The intervention includes advanced perfusion imaging processing using the HTS methodology, non-invasive tumor characterization, and integration with molecular and histopathological data.
| Study group | Role | What they receive |
|---|---|---|
| Patients with IDH-wildtype Glioblastoma | Patients with IDH-wildtype glioblastoma who have undergone a pre-surgical MRI study Receives: Device: The ONCOhabitats software for MRI-based habitat segmentation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival
Imaging biomarkers-including relative cerebral blood volume (rCBV), volume (cm³), and radiomic vascular heterogeneity metrics-will be extracted from the peritumoral infiltrated edema (IPE) habitat using the ONCOhabitats platform on preoperative MRI. These biomarkers will be quantitatively assessed for their association with overall survival. Overall survival is defined as the time from surgical resection to death from any cause, with a follow-up of up to 24 months. Statistical analysis will include Kaplan-Meier survival estimation and Cox proportional hazards regression models.
Measured: Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery
Secondary outcomes (8)
Gene Expression Profiles in the IPE Region Associated With Poor Response to Immunotherapy in IDH-Wildtype Glioblastoma
Gene expression analysis will be performed on tissue samples obtained from the peritumoral infiltrated edema (IPE) region during surgical resection. RNA sequencing (RNA-seq) or targeted transcriptomic panels will be used to identify differential expression of immunosuppressive and immune-regulatory genes (e.g., PD-L1, CTLA-4, TGF-β, IDO1) in patients with IDH-wildtype glioblastoma. These molecular profiles will be correlated with clinical response to immunotherapy, as defined by progression-free survival (PFS) and overall survival (OS),
Measured: Tissue samples collected at surgery; clinical follow-up for up to 24 months
Histopathological Features in Tumor (HAT, LAT) and Edema (IPE, VPE) Habitats Defined by ONCOhabitats in IDH-Wildtype Glioblastoma
Histopathological analysis will be conducted on tissue samples obtained from four MRI-derived habitats segmented using the ONCOhabitats software platform:
- HAT (High Angiogenic Tumor) and LAT (Low Angiogenic Tumor), corresponding to tumor regions
- IPE (Infiltrated Peritumoral Edema) and VPE (Vasogenic Peritumoral Edema), corresponding to peritumoral edema regions
Tissue sections will be evaluated using hematoxylin and eosin (H\&E) staining and immunohistochemistry to characterize features such as cellularity, necrosis, microvascular proliferation, immune cell infiltration, and other relevant histopathological traits. The aim is to describe and compare the biological composition of tumor versus edema habitats.
Measured: Tissue samples collected at the time of surgical resection
Levels of Immunosuppressive Gene Expression in MRI-Derived Habitats (IPE, HAT, VPE)
Tissue samples will be collected from three MRI-derived habitats defined by the ONCOhabitats platform in patients with IDH-wildtype glioblastoma:
- IPE (Infiltrated Peritumoral Edema)
- HAT (High Angiogenic Tumor)
- VPE (Vasogenic Peritumoral Edema)
Immunohistochemical and transcriptomic analyses will be performed to quantify the expression of immunosuppressive markers, including but not limited to PD-L1, CTLA-4, TGF-β, and IDO1. The level of immunosuppressive activity in each habitat will be characterized to explore spatial heterogeneity in the tumor microenvironment.
Measured: Tissue samples collected at the time of surgical resection
Association Between Perfusion Imaging Biomarkers and Molecular Markers in IDH-Wildtype Glioblastoma
Quantitative perfusion biomarkers-such as relative cerebral blood volume (rCBV), cerebral blood flow (CBF), and Ktrans-will be obtained from preoperative MRI processed with the ONCOhabitats platform. These imaging-derived parameters will be correlated with molecular markers obtained from tumor and edema tissue samples, including MGMT promoter methylation, IDH mutation status, and expression of immune-related genes (e.g., PD-L1, CTLA-4). The aim is to explore associations between vascular imaging features and the underlying molecular profile of IDH-wildtype glioblastoma.
Measured: MRI performed preoperatively; molecular analysis from tissue samples collected during surgery
Predictive Value of Combined Imaging, Histopathological, Molecular, and Cellular Biomarkers in IDH-Wildtype Glioblastoma
Multimodal biomarkers-including perfusion imaging features (e.g., relative cerebral blood volume [rCBV], cerebral blood flow [CBF]), histopathological traits (e.g., vascular proliferation, immune infiltration), molecular alterations (e.g., MGMT promoter methylation, gene expression profiles), and cellular markers (e.g., CD3+, CD8+ lymphocyte density)-will be integrated using multivariate models and artificial intelligence (AI) techniques to predict clinical outcomes in patients with IDH-wildtype glioblastoma. These outcomes include diagnosis, prognosis (e.g., overall survival), and treatment response-based patient stratification.
Measured: Biomarker data collected at surgery; clinical follow-up up to 24 months post-surgery
Stratification Biomarkers for Surgical Resection of the IPE Region or Local Immunotherapy in the Resection Cavity
Histopathological, molecular, and imaging biomarkers will be analyzed to identify features that allow for patient stratification regarding two therapeutic approaches: (1) surgical resection of the infiltrated peritumoral edema (IPE) region, and (2) administration of local therapies such as immunotherapy in the resection cavity. Biomarkers may include, among others, perfusion imaging parameters (e.g., rCBV), gene expression profiles related to immune activation or suppression, and histopathological indicators of tumor infiltration and immune cell presence. These variables will be evaluated for their potential to guide individualized treatment decisions in IDH-wildtype glioblastoma.
Measured: Biomarker data collected at surgery; follow-up up to 24 months
Patient Stratification Based on MGMT Promoter Methylation Status and rCBV for Response to Temozolomide in IDH-Wildtype Glioblastoma
The association between MGMT promoter methylation status and relative cerebral blood volume (rCBV)-measured from preoperative dynamic susceptibility contrast (DSC) MRI using the ONCOhabitats platform-will be evaluated to stratify patients with IDH-wildtype glioblastoma according to their response to temozolomide (TMZ) treatment. Response will be assessed based on progression-free survival (PFS) and overall survival (OS) over a follow-up period of up to 24 months. The predictive value of the combined biomarkers will be analyzed using multivariate models and ROC curve analysis.
Measured: MGMT and rCBV data collected at baseline (before treatment); follow-up up to 24 months
Correlation Between MGMT Methylation Status Assessed by Immunohistochemistry and MLPA and Response to Temozolomide in IDH-Wildtype Glioblastoma
MGMT promoter methylation status will be assessed in tumor tissue samples using two methods: immunohistochemistry (IHC) and multiplex ligation-dependent probe amplification (MLPA). The results of both techniques will be compared to evaluate their concordance and their respective predictive value for response to temozolomide (TMZ) in patients with IDH-wildtype glioblastoma. Response will be measured using progression-free survival (PFS) and overall survival (OS) over a 24-month follow-up period.
Measured: MGMT methylation status assessed at baseline; clinical follow-up up to 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2025
- Study start16 Jul 2024
- Primary completionSep 2026 (estimated)
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Glioblastoma IDH (Isocitrate Dehydrogenase) WildtypeStudies 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
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Juan M Garcia-Gomez
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia, Hospital Universitario de Canarias, Hospital General Universitario de Alicante, Hospital Universitario Virgen de la Arrixaca, Hospital Vall d'Hebron
- Responsible party
- Sponsor-investigator, Juan M Garcia-Gomez, Universitat Politècnica de València
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07111195
- Sponsor's protocol ID
- INNEST/2022/087
- Acronym
- SINUE
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 8 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Juan-Albarracin J, Fuster-Garcia E, Perez-Girbes A, Aparici-Robles F, Alberich-Bayarri A, Revert-Ventura A, Marti-Bonmati L, Garcia-Gomez JM. Glioblastoma: Vascular Habitats Detected at Preoperative Dynamic Susceptibility-weighted Contrast-enhanced Perfusion MR Imaging Predict Survival. Radiology. 2018 Jun;287(3):944-954. doi: 10.1148/radiol.2017170845. Epub 2018 Jan 19.
PubMed 29357274Del Mar Alvarez-Torres M, Juan-Albarracin J, Fuster-Garcia E, Bellvis-Bataller F, Lorente D, Reynes G, Font de Mora J, Aparici-Robles F, Botella C, Munoz-Langa J, Faubel R, Asensio-Cuesta S, Garcia-Ferrando GA, Chelebian E, Auger C, Pineda J, Rovira A, Oleaga L, Molla-Olmos E, Revert AJ, Tshibanda L, Crisi G, Emblem KE, Martin D, Due-Tonnessen P, Meling TR, Filice S, Saez C, Garcia-Gomez JM. Robust association between vascular habitats and patient prognosis in glioblastoma: An international multicenter study. J Magn Reson Imaging. 2020 May;51(5):1478-1486. doi: 10.1002/jmri.26958. Epub 2019 Oct 26.
PubMed 31654541Juan-Albarracin J, Fuster-Garcia E, Garcia-Ferrando GA, Garcia-Gomez JM. ONCOhabitats: A system for glioblastoma heterogeneity assessment through MRI. Int J Med Inform. 2019 Aug;128:53-61. doi: 10.1016/j.ijmedinf.2019.05.002. Epub 2019 May 16.
PubMed 31160012
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Evaluation of ONCOhabitats for Supporting Surgical and Therapeutic Planning in Patients With IDH-Wildtype Glioblastoma (SINUE)
- ClinicalTrials.gov ID
- NCT07111195
- Acronym / sponsor ID
- SINUE / INNEST/2022/087
- Keywords
- Glioblastoma, IHD-wildtype, MRI, Biomarkers, Perfussion, Tumor heterogenity, Peritumoral edema, Tumor Infiltration
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Juan M Garcia-GomezUniversity, hospital or other
- Collaborators
- Hospital Clínico Universitario de Valencia, Hospital Universitario de Canarias, Hospital General Universitario de Alicante, Hospital Universitario Virgen de la Arrixaca, Hospital Vall d'Hebron
- Study start
- 16 Jul 2024 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2026 (estimated)
- First posted
- 8 Aug 2025 (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.
The goal of this clinical trial is to validate ONCOhabitats, an advanced imaging software, as a medical device for the clinical management of IDH-wildtype glioblastoma.
The study aims to evaluate whether imaging biomarkers derived from pre-surgical MRI using ONCOhabitats can predict overall survival and support clinical decision-making.
The primary research questions are:
- Can ONCOhabitats identify vascular and molecular characteristics within the peritumoral infiltrated edema (IPE) that are associated with patient prognosis?
- Can these imaging biomarkers aid in stratifying patients according to their response to treatment, including temozolomide and immunotherapy?
Participants will:
- Be adults diagnosed with high-grade glioma who are scheduled for surgical tumor resection
- Undergo preoperative MRI processed with ONCOhabitats to segment the tumor into four biological habitats (HAT, LAT, IPE, and VPE)
- Provide tissue samples from each habitat when feasible, based on surgical and clinical considerations
Researchers will analyze:
- Imaging biomarkers (e.g., relative cerebral blood volume, rCBV)
- Molecular and histopathological features (e.g., MGMT promoter methylation, gene expression profiles associated with immunosuppression)
- Clinical and survival outcomes
This study seeks to enhance glioblastoma characterization and support personalized treatment strategies through the clinical validation of a software platform.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with IDH-wildtype Glioblastoma | – | Device: The ONCOhabitats software for MRI-based habitat segmentationPatients with IDH-wildtype glioblastoma who have undergone a pre-surgical MRI study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years old) with a radiological diagnosis of IDH-wildtype glioblastoma who are candidates for surgical resection. All participants must have a complete preoperative MRI study, including advanced perfusion sequences, and must provide written informed consent.
Key inclusion criteria (9 listed)
- Adults (≥18 years old) at the time of diagnosis
- Radiological diagnosis of high-grade glioma
- Candidates for surgical resection
- Availability of complete preoperative MRI studies, including:
- T1-weighted MRI (pre- and post-gadolinium)
Key exclusion criteria (5 listed)
- Patients who do not provide informed consent
- Patients deemed inoperable
- MRI data that cannot be processed using ONCOhabitats
- Patient withdraws informed consent at any time
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 |
|---|---|---|
| The ONCOhabitats software for MRI-based habitat segmentationONCOhabitats is an MRI-based software platform designed to segment IDH-wildtype glioblastomas into four biologically distinct habitats (HAT, LAT, IPE, and VPE) based on vascular heterogeneity. In this study, the software is applied preoperatively to generate imaging biomarkers that guide surgical sampling and are assessed for their ability to predict overall survival and stratify patients accordingly. The intervention includes advanced perfusion imaging processing using the HTS methodology, non-invasive tumor characterization, and integration with molecular and histopathological data. | Device | Patients with IDH-wildtype Glioblastoma |
Primary outcome
Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival
Time frame: Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery
Imaging biomarkers-including relative cerebral blood volume (rCBV), volume (cm³), and radiomic vascular heterogeneity metrics-will be extracted from the peritumoral infiltrated edema (IPE) habitat using the ONCOhabitats platform on preoperative MRI. These biomarkers will be quantitatively assessed for their association with overall survival. Overall survival is defined as the time from surgical resection to death from any cause, with a follow-up of up to 24 months. Statistical analysis will include Kaplan-Meier survival estimation and Cox proportional hazards regression models.
8 secondary outcomes
Gene Expression Profiles in the IPE Region Associated With Poor Response to Immunotherapy in IDH-Wildtype Glioblastoma
Time frame: Tissue samples collected at surgery; clinical follow-up for up to 24 months
Histopathological Features in Tumor (HAT, LAT) and Edema (IPE, VPE) Habitats Defined by ONCOhabitats in IDH-Wildtype Glioblastoma
Time frame: Tissue samples collected at the time of surgical resection
Levels of Immunosuppressive Gene Expression in MRI-Derived Habitats (IPE, HAT, VPE)
Time frame: Tissue samples collected at the time of surgical resection
Association Between Perfusion Imaging Biomarkers and Molecular Markers in IDH-Wildtype Glioblastoma
Time frame: MRI performed preoperatively; molecular analysis from tissue samples collected during surgery
Predictive Value of Combined Imaging, Histopathological, Molecular, and Cellular Biomarkers in IDH-Wildtype Glioblastoma
Time frame: Biomarker data collected at surgery; clinical follow-up up to 24 months post-surgery
Stratification Biomarkers for Surgical Resection of the IPE Region or Local Immunotherapy in the Resection Cavity
Time frame: Biomarker data collected at surgery; follow-up up to 24 months
Patient Stratification Based on MGMT Promoter Methylation Status and rCBV for Response to Temozolomide in IDH-Wildtype Glioblastoma
Time frame: MGMT and rCBV data collected at baseline (before treatment); follow-up up to 24 months
Correlation Between MGMT Methylation Status Assessed by Immunohistochemistry and MLPA and Response to Temozolomide in IDH-Wildtype Glioblastoma
Time frame: MGMT methylation status assessed at baseline; clinical follow-up up to 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2025.
- Background: PubMed 29357274Juan-Albarracin J, Fuster-Garcia E, Perez-Girbes A, Aparici-Robles F, Alberich-Bayarri A, Revert-Ventura A, Marti-Bonmati L, Garcia-Gomez JM. Glioblastoma: Vascular Habitats Detected at Preoperative Dynamic Susceptibility-weighted Contrast-enhanced Perfusion MR Imaging Predict Survival. Radiology. 2018 Jun;287(3):944-954. doi: 10.1148/radiol.2017170845. Epub 2018 Jan 19.
- Background: PubMed 31654541Del Mar Alvarez-Torres M, Juan-Albarracin J, Fuster-Garcia E, Bellvis-Bataller F, Lorente D, Reynes G, Font de Mora J, Aparici-Robles F, Botella C, Munoz-Langa J, Faubel R, Asensio-Cuesta S, Garcia-Ferrando GA, Chelebian E, Auger C, Pineda J, Rovira A, Oleaga L, Molla-Olmos E, Revert AJ, Tshibanda L, Crisi G, Emblem KE, Martin D, Due-Tonnessen P, Meling TR, Filice S, Saez C, Garcia-Gomez JM. Robust association between vascular habitats and patient prognosis in glioblastoma: An international multicenter study. J Magn Reson Imaging. 2020 May;51(5):1478-1486. doi: 10.1002/jmri.26958. Epub 2019 Oct 26.
- Background: PubMed 31160012Juan-Albarracin J, Fuster-Garcia E, Garcia-Ferrando GA, Garcia-Gomez JM. ONCOhabitats: A system for glioblastoma heterogeneity assessment through MRI. Int J Med Inform. 2019 Aug;128:53-61. doi: 10.1016/j.ijmedinf.2019.05.002. Epub 2019 May 16.
- ONCOhabitats websiteLink provided by the sponsor.
- 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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma IDH (Isocitrate Dehydrogenase) Wildtype, run by Juan M Garcia-Gomez at 5 sites in Spain.
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 9 inclusion and 5 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 8 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Spain. 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 Juan Miguel García Gómez, PhD, Full Professor (+34 963877069, juanmig@upv.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association of ONCOhabitats-Derived Vascular Biomarkers in the IPE Region With Overall Survival (time frame: Imaging biomarkers at surgery (baseline); overall survival followed for up to 24 months post-surgery). 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 NCT07111195, which also lists 3 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 8 Aug 2025.