Study of Prognostic Biomarkers of Survival at 6 Months for Patients Treated With Bevacizumab Glioblastomas in First Relapse After Failure of Radiochemotherapy
NCT ID: NCT03144167
Last Updated: 2026-01-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
170 participants
INTERVENTIONAL
2019-06-18
2027-01-20
Brief Summary
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These biomarkers are based on the increase of an index combining choline / Creatine (Cho / Cr), Glx / Cr (Glutamine and glutamate / Creatine), NAA / Cr (N acetyl aspartate / Creatine) and lactate / Cr ratios. The long-term objective is to predict the survival of these relapsed GBM patients at an early stage and to identify responder patients who would benefit from this expensive molecule and avoid using it in non-responding patients
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
OTHER
NONE
Study Groups
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Patients, aged 18-88, with glioblastoma
Analysis of spectroscopic biomarkers of proliferation for six-month survival
Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival
Interventions
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Analysis of spectroscopic biomarkers of proliferation for six-month survival
Analysis of spectroscopic biomarkers of proliferation, glial reaction, infiltration and glutaminergic metabolism or glycolytic metabolism for six-month survival
Eligibility Criteria
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Inclusion Criteria
* Biological Criteria
* Polymorphonuclear neutrophils\> 1500 / mm3
* Plates\> 100,000 / mm3
* SGOT-SGPT \<5 at the upper limit of normal (ULN)
* Bilirubin \<1.5 x ULN
* Creatinine \<1.5 LSN and creatinine clearance
* Proteinuria \<1 g / 24 hours
* Patient with health insurance
* Consent signed by the patient if he is lucid, or failing that by the person of trust
Exclusion Criteria
* Symptomatic cerebral or tumor hemorrhage
* Karnofsky Index less than 50% or
* Patients already treated with an antiangiogenic molecule or Gliadel (diagnosis and recurrence).
* Coagulation disorders in case of injectable treatment (especially for avastin),
* Contraindications known to the MRI: Pace Makers, foreign bodies intraocular, electrodes ...
* Uncontrolled severe concomitant pathology, including another evolving cancer (with the exception of operative cutaneous tumors, in situ cancer of the cervix or breast treated).
* Uncontrolled Infection
* Uncontrolled hypertension (PAS\> 160 mm Hg) despite optimized treatment
* Coronary artery disease or unstable arterial disease. Evolutionary aneurysm.
* Myocardial infarction dating from less than 6 months.
* Peripheral arterial or cerebrovascular accident occurring less than 6 months.
* Heart Failure\> grade II NYHA
* Hemorrhagic Disease (Hemophilia, Willebrandt ...)
* Nephrotic syndrome with proteinuria\> 2 g / 24 h
* History of haemoptysis dating less than 1 month.
* Pulmonary embolism dating less than 1 month.
* Surgical intervention (other than craniotomy or stereotactic biopsy) dating less than one month or essential and predictable surgery.
* History of digestive fistula or intestinal perforation with resolution less than 6 months.
* Hypersensitivity to bevacizumab or to any of the excipients mentioned in Composition.
* Hypersensitivity to Chinese hamster ovary (CHO) cells or to other human or humanized recombinant antibodies.
* Severe Myelosuppression
* Pregnant or nursing. Contraception should be prescribed if necessary during treatment.
* Persons deprived of liberty or placed under safeguard of justice (guardianship or curatorship),
* Subject involved in another search including an exclusion period still in progress at pre-inclusion
* Patient refusing to participate in the study
18 Years
ALL
No
Sponsors
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Centre Hospitalier Universitaire, Amiens
OTHER
Responsible Party
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Locations
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CHU Amiens Picardie
Amiens, Picardie, France
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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PI2016_843_0027
Identifier Type: -
Identifier Source: org_study_id
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