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Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	50 Years - 75 Years
Gender	All

More Inclusion & Exclusion Criteria

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)

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT03630861
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Assistance Publique - Hôpitaux de Paris
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Completed
Countries	France
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Brain Tumors

Additional Details

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.

Arms & Interventions

Arms

: GBM

Primary glioblastoma (GBM)

: PCNSL

Primary CNS lymphomas (PCNSL)

: Brain metastases

Brain metastases (BM)

: Cerebral Stroke

Cerebral Stroke (CS)

: Healthy Volunteers

Healthy Volunteers (HV)

Interventions

Contact a Trial Team

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International Sites

Groupe Hospitalier Pitié-Salpêtrière, Paris, France

Status

Address

Groupe Hospitalier Pitié-Salpêtrière

Paris, , 75013

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