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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-A00503-46 | Registry Identifier | IDRCB |
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MIRNA is a prospective multi-center observational study designed to explore 762 plasma microRNAs in patients with malignant CNS tumours: 60 primary glioblastoma (GBM), 20 primary CNS lymphomas and 40 brain metastases in an attempt to establish plasma microRNA signatures specific to GBM capable of distinguishing them from malignant non-glial brain tumours. 20 patients with cerebral stroke and 20 healthy volunteers will also participate in the study, and for each patient, a panel of 762 microRNAs will be screened in plasma.
Neuro-oncology faces two challenges: establishing an accurate, rapid diagnosis and having early therapeutic response. This applies particularly to glioblastoma (GBM) since the positive diagnosis is evoked on MRI imaging and the diagnosis of certainty provided by anatomopathology. There are no perfect techniques and there are problems of differential diagnosis in imaging. Sometimes the context does not allow biopsy or excision.
This study is a prospective multi-center observational study designed to be conducted in patients with malignant CNS tumours: primary glioblastoma (60 GBM), primary CNS lymphomas (20 PCNSL), brain metastases (40 BM), in an attempt to establish plasma microRNA signatures characteristic of a tumour process. Patients with cerebral stroke (20 CS) and healthy volunteers (20 HV) will also participate in the study. For each patient, a panel of 762 microRNAs will be screened in plasma.
First, the investigators will focus on the potentially diagnostic nature of the signature, which may prove useful when there are problems of differential diagnosis in imaging or when the context does not permit biopsy or excision. The main objective of the study is to establish a plasma microRNA signature specific to GBM, capable of distinguishing them from malignant non-glial brain tumours (PCNSL and BM). Within the main objective, discrimination will be established between GBM and malignant non-glial brain tumours.
Secondly, the quantitative approach of plasma miRNoma with 752 microRNAs studied in the different patient groups will allow for other objectives:1/ Establish plasma microRNA signatures characteristic of other types of brain tumours; 2/ Identify a plasma microRNA signature characteristic of the cerebral injury component independently of the tumor component with the CS and HV groups; 3/ Identify plasma microRNA signatures characteristic of GBM subtypes in relation to their genomic alterations; 4/ Establish correlations between plasma microRNA expression levels and data collected through multi-modality MRI imaging and anatomopathology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GBM | Primary glioblastoma (GBM) | ||
| PCNSL | Primary CNS lymphomas (PCNSL) | ||
| Brain metastases | Brain metastases (BM) | ||
| Cerebral Stroke | Cerebral Stroke (CS) | ||
| Healthy Volunteers | Healthy Volunteers (HV) |
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| Measure | Description | Time Frame |
|---|---|---|
| QR (relative amount) | QR (relative amount) of each plasma microRNA for GBM and non-glial tumors (PCNSL, BM). | Up to 3 months after the end of all samplings. |
| Measure | Description | Time Frame |
|---|---|---|
| QR value of each microRNA for all groups | QR value of each microRNA for all groups | Up to 3 months after the end of all samplings |
| Genetic abnormalities | Genetic abnormalities of GBM subtypes |
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Inclusion Criteria:
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Brain tumors: GBM, PCNSL, BM
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Groupe Hospitalier Pitié-Salpêtrière | Paris | 75013 | France |
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| ID | Term |
|---|---|
| D001932 | Brain Neoplasms |
| D005909 | Glioblastoma |
| D020521 | Stroke |
| D004194 | Disease |
| ID | Term |
|---|---|
| D016543 | Central Nervous System Neoplasms |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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Plasma and serum samples aliquoted and stored may be used either for re-analysis if necessary for the current study or as part
| Up to 3 months after the end of the study |
| Main imaging and anatomopathology characteristics | Description of main imaging and anatomopathological characteristics | Up to 3 months after the end of the study |
| D001927 |
| Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D001254 | Astrocytoma |
| D005910 | Glioma |
| D018302 | Neoplasms, Neuroepithelial |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D002561 | Cerebrovascular Disorders |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |