Brain Tumors Clinical Trial
— MIRNAOfficial title:
Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults
Verified date | April 2018 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 160 |
Est. completion date | November 2017 |
Est. primary completion date | October 5, 2017 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility |
Inclusion Criteria: 1. Inclusion criteria applicable to all study subject: adults aged between 50 and 75, affiliated to social protection and having signed a consent form. 2. Inclusion criteria for patients with a brain tumor (GBM, PCNSL): patients with clinical symptomatology and imaging suggestive of brain tumor, for whom a biopsy will be performed to make the diagnosis of certainty 3. Inclusion criteria for patients with BM: a priori asymptomatic patients who received treatment by stereotactic radiosurgery (gamma-knife) for small circumscribed BM (diameter < 3cm, less than 3) 4. Inclusion criteria for patients with CS: patients with clinical symptoms and imaging suggestive of acute stroke (< 24 hours, NIHSS score >5) |
Country | Name | City | State |
---|---|---|---|
France | Groupe Hospitalier Pitié-Salpêtrière | Paris |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | |
Secondary | 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 | |
Secondary | Genetic abnormalities | Genetic abnormalities of GBM subtypes | Up to 3 months after the end of the study | |
Secondary | Main imaging and anatomopathology characteristics | Description of main imaging and anatomopathological characteristics | Up to 3 months after the end of the study |
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