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Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features. (MM-Predict)

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ClinicalTrials.gov Identifier: NCT03526822
Recruitment Status : Recruiting
First Posted : May 16, 2018
Last Update Posted : July 24, 2018
Sponsor:
Information provided by (Responsible Party):
Assistance Publique Hopitaux De Marseille

Study Description
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Brief Summary:

Glioblastoma is the most frequent and aggressive primary brain tumor in adults. A team recently showed that baseline plasma levels of matrix metalloproteinase-2 (MMP2) and matrix metalloproteinase-9 (MMP9) were correlated to bevacizumab activity in patients with recurrent glioblastoma. To date, the biological rationale of this results remains unknown but MMP2 could be involved in classical angiogenesis while MMP9 could promote vasculogenesis.

The objectives are to correlate the plasma levels of MMP2 and MMP9 to their Ribonucleic acid (RNA) and protein tissue expression, activity and to patient neuro-imaging features. To analyze the changes of MMP2 and MMP9 plasma levels during peri-operative period and after radio-chemotherapy.

Methods: Plasmatic levels of MMP2, MMP9, vascular endothelial growth factor-A (VEGFA), vascular endothelial growth factor-R2 (VEGFR2), stromal cell-derived factor 1 (SDF1) and chemokine receptor-4 (CXCR4) will be analyzed by enzyme-linked immunosorbent assay (ELISA) in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma. RNA expression of these factors will be analyzed by reverse transcription-Polymerase chain reaction (RT-qPCR) on frozen tumor samples, whereas protein expression will be analyzed by ELISA and immunohistochemistry. Enzymatic activity of MMP2 and MMP9 will be analyzed by zymography. Tumor volume, infiltration and perfusion degrees will be analyzed on Magnetic Resonance Imaging (MRI) performed before and after surgery and before adjuvant temozolomide. Neuro-imaging characteristics will be correlated to plasma and tissue expressions of these factors.

The expected results are to better define the expression profile of MMP2, MMP9 and the change in their plasma level during treatment, a prerequisite for their clinical use.


Condition or disease Intervention/treatment Phase
Brain Tumor Biological: Blood sample Biological: Tumor sample Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Prospective Cohort of Patients With Newly Diagnosed Glioblastoma: Analysis of MMP2 and MMP9 Expression and Correlation to Neuro-imaging Features.
Actual Study Start Date : July 2, 2018
Estimated Primary Completion Date : January 1, 2022
Estimated Study Completion Date : May 1, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: patients with newly diagnosed glioblastoma Biological: Blood sample
Five blood sample in pre-, post-operative period, before radiotherapy, before adjuvant temozolomide and at relapse in newly diagnosed glioblastoma

Biological: Tumor sample
One tumor sample in operative period


Outcome Measures
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Primary Outcome Measures :
  1. correlate the plasma levels of MMP2 and MMP9 to their RNA and protein tissue expression by ELISA [ Time Frame: 18 months ]
    identify potential temporal variations of these markers


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patient, male or female, aged 18 years or over
  • Imaging suggestive of glioblastoma
  • Patient eligible for excision surgery (partial, subtotal or macroscopically complete)
  • Candidate for concomitant and adjuvant radiotherapy chemotherapy (Stupp protocol)
  • Patient having signed an informed consent
  • Patient having undergone a preoperative MRI

Exclusion Criteria:

  • Existence of a contraindication to the MRI
  • Nonoperable lesion
  • History of radiotherapy and / or chemotherapy for this lesion
  • Scalability of a low grade lesion
  • Person in emergency situation, a legal person of legal age (guardianship, guardianship or legal guardianship), or unable to express his or her consent
  • No affiliation to a social security scheme (beneficiary or beneficiary)
  • Pregnant or lactating woman
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03526822


Contacts
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Contact: Emeline TABOURET, PH 491385500 ext +33 emeline.tabouret@ap-hm.fr
Contact: Dominique FIGARELLA, PU-PH 413429011 ext +33 dominique.figarella-branger@ap-hm.fr

Locations
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France
Assistance Publique Hôpitaux de Marseille Recruiting
Marseille, France, 13354
Contact: Emeline TABOURET, PH    491385500 ext +33    emeline.tabouret@ap-hm.fr   
Contact: Dominique FIGARELLA, PU-PH    413429011 ext +33    dominique.figarella-branger@ap-hm.fr   
Principal Investigator: Emeline TABOURET, PH         
Sub-Investigator: Olivier CHINOT, PU-PH         
Sub-Investigator: Philippe METELLUS, PU-PH         
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Jean-Olivier ARNAUD, Director Assistance Publique Hôpitaux de Marseille
More Information
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT03526822    
Other Study ID Numbers: 2017-56
2018-A00740-55 ( Registry Identifier: ID RCB )
First Posted: May 16, 2018    Key Record Dates
Last Update Posted: July 24, 2018
Last Verified: May 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
 Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue