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
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|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
- 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
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
|Contact: Emeline TABOURET, PH||491385500 ext +firstname.lastname@example.org|
|Contact: Dominique FIGARELLA, PU-PH||413429011 ext +email@example.com|
|Assistance Publique Hôpitaux de Marseille||Recruiting|
|Marseille, France, 13354|
|Contact: Emeline TABOURET, PH 491385500 ext +33 firstname.lastname@example.org|
|Contact: Dominique FIGARELLA, PU-PH 413429011 ext +33 email@example.com|
|Principal Investigator: Emeline TABOURET, PH|
|Sub-Investigator: Olivier CHINOT, PU-PH|
|Sub-Investigator: Philippe METELLUS, PU-PH|
|Study Director:||Jean-Olivier ARNAUD, Director||Assistance Publique Hôpitaux de Marseille|