| Registry | NCT07211841, acronym GLIOMIT |
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| Status | Not yet recruiting |
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| Phase | Not applicable |
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| Study type | Interventional; na, single group, masking: none, other |
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| Enrollment | 30 (Estimated) |
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| Sponsor | Centre Hospitalier Universitaire, Amiens (Other) |
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| Conditions | Glioblastoma, MRI Spectroscopy, Tumor Microenvironment, Biomarkers / Blood |
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| Interventions | MRS study, blood samples (Device, biological) |
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| Dates | start 2025-12-01 (estimated), primary completion 2027-04-01 (estimated), completion 2029-04-01 (estimated), first posted 2025-10-08, last updated 2025-11-19 |
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| Locations | 1 site in France |
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Related Papers Related Patents Related Grants Related Experts
All trials for Glioblastoma All trials for MRI Spectroscopy All trials of MRS study All trials of blood samples
-Summary
Glioblastoma multiforme (GBM) is the most common primary brain tumor, and it is well-known to be associated with a poor prognosis. MRI is the key medical technique for the diagnosis and the follow-up of GBM. By allowing for MRS studies, MRI permits a non-invasive characterization of the TME of GBM, including their metabolic characterization. The investigators propose to address the link between the MRS profile of GBM and basic clinical and biological parameters, with the aim of : i) identifying correlations between these parameters, ii) attempting to integrate clinical, biological and spectroscopic profiles of GBM. The investigators plan to recruit 30 newly diagnosed GBM patients for which surgery / radiochemotherapy will be proposed in the Medical oncology unit of Amiens University Hospital. Following inclusion of patients with probable GBM, MRS study will be performed during the first (pre-therapeutic) MRI examination. Basic clinical and biological parameters of the blood (CRP, complete blood count, fibrinogen, lactate and choline) will be assessed. A metabolomic study will also be performed on the plasma of GBM patients before any therapeutics. A second biological, post-therapeutic assesment (one month after surgery/radiochemotherapy) will allow the same analyses (basic biological parameters + plasma metabolomics), in order to examine the stability of the blood parameters.
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+Arms and interventions
- MRS study (Device): Thirty patients newly diagnosed with GBM will be included in this study. The study will be conducted without any major modification of the standard management of GBM.
The MRS study will be performed at the time of the initial MRI examination (morphological MRI sequences performed on 3T Philipps). The MRS will be performed on the most agressive part of the tumor : monovoxel PRESS MRS sequence with 3 echo times : 35, 144 and 288 ms. Spectra processing with Philipps software returns relative quantifications > 7 ratios (choline/creatin, Glucose/creatin, glutamine/creatin, N-Acetyl aspartate/creatin, myoinositol/creatin, phsopholipids/creatin, lactate/creatin, acetate/creatin). With this experimental design, the additional time required for MRS acquisition is 10 min /patient.
- blood samples (Biological): Routine basic clinical and biological analyses will be collected during the project. In addition, 2 blood samples (5 mL each time) will be obtained at the time of inclusion (pre-therapeutic) and one month after completion of the initial therapeutic cycle (surgery + radiochemotherapy). The plasma samples will be used to measure fibrinogen, lactate and choline concentrations. In addition, a metabolomic study of plasma will be performed w
+Outcome measures
Primary outcomes
- Correlations between initial spectroscopic parameters, basic clinical and biological informations [12 months]: correlations between initial spectroscopic parameters of the tumor, basic clinical information and biological assessment of the blood in a cohort of newly-diagnosed GBM
Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
Secondary outcomes
- Variation from baseline of blood parameters [at 1 month]: Variation from baseline of blood parameters at one month after surgery/radiochemotherapy in each patient. Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
- Progression-free survival [at 12 months]
- Overall survival [at 12 months]
- Correlation of biological and metabolomic data with progression-free survival [at 12 months]: Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
- Correlation of biological and metabolomic data with overall survival [at 12 months]: Blood parameters are choline, creatinine, lactate, glutamate/glutamine, alanine, glycine. For each parameter, absolute concentrations will be measured. A Z transformation will be used as a preliminary step ahead of all analyses (heat map construction, testing correlations).
+Eligibility
Sex: All, ages: 18 Years to any
Inclusion Criteria:
* Patients consecutively identified in the multidisciplinary consultation meeting of neurooncology with a new diagnosis of GBM / a probable diagnosis of GBM. - Patients that have not started radiochemotherapy ;
* Adult > 18 yrs
* socially-insured,
* having given consent.
Exclusion Criteria:
* minor patients,
* pregnant/lactating women,
* patients under guardianship,
* curatorship,
* protection of justice or deprived of liberty
+Locations (1)
| Facility | City | Country | Status |
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| CHU Amiens | Amiens | France | |