Brain TumorsMIRNANCT03630861
Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults
An observational study of Brain Tumors, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Brain Tumors
- How many people
- 160 participants
- Where
- 1 siteFrance
- Study dates
- 10 Jan 2016to Nov 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Brain tumors: GBM, PCNSL, BM
Who may be able to join
- Inclusion criteria applicable to all study subject: adults aged between 50 and 75, affiliated to social protection and having signed a consent form.
- 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
- 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)
- Inclusion criteria for patients with CS: patients with clinical symptoms and imaging suggestive of acute stroke (< 24 hours, NIHSS score >5)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
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.
- Conditions
- Brain Tumors
- Keywords
- MicroRNAs, Glioblastoma, nonglial tumors, stroke, diagnosis
- Medical subject headings
- Brain Neoplasms, Glioblastoma, Stroke, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GBM | Primary glioblastoma (GBM) | |
| PCNSL | Primary CNS lymphomas (PCNSL) | |
| Brain metastases | Brain metastases (BM) | |
| Cerebral Stroke | Cerebral Stroke (CS) | |
| Healthy Volunteers | Healthy Volunteers (HV) |
What is being measured
The primary outcome is the main question the study is designed to answer.
QR (relative amount)
QR (relative amount) of each plasma microRNA for GBM and non-glial tumors (PCNSL, BM).
Measured: Up to 3 months after the end of all samplings.
Secondary outcomes (3)
QR value of each microRNA for all groups
QR value of each microRNA for all groups
Measured: Up to 3 months after the end of all samplings
Genetic abnormalities
Genetic abnormalities of GBM subtypes
Measured: Up to 3 months after the end of the study
Main imaging and anatomopathology characteristics
Description of main imaging and anatomopathological characteristics
Measured: Up to 3 months after the end of the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Aug 2018
- Study start10 Jan 2016
- Primary completion5 Oct 2017
- Study completionNov 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain TumorsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03630861
- Sponsor's protocol ID
- NI 14007
- Other IDs
- 2015-A00503-46
- Acronym
- MIRNA
- Status last verified
- Apr 2018
- First submitted
- 10 Apr 2018
- Last updated
- 15 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Signature of Circulating microRNA as a Tool to Aid Diagnosis of Primary Brain Tumors in Adults
- ClinicalTrials.gov ID
- NCT03630861
- Acronym / sponsor ID
- MIRNA / NI 14007
- Conditions
- Brain Tumors
- Keywords
- MicroRNAs, Glioblastoma, nonglial tumors, stroke, diagnosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 10 Jan 2016 (actual)
- Primary completion
- 5 Oct 2017 (actual)
- Study completion
- Nov 2017 (actual)
- First posted
- 15 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GBM | – | –Primary glioblastoma (GBM) |
| PCNSL | – | –Primary CNS lymphomas (PCNSL) |
| Brain metastases | – | –Brain metastases (BM) |
| Cerebral Stroke | – | –Cerebral Stroke (CS) |
| Healthy Volunteers | – | –Healthy Volunteers (HV) |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Brain tumors: GBM, PCNSL, BM
Key inclusion criteria (4 listed)
- Inclusion criteria applicable to all study subject: adults aged between 50 and 75, affiliated to social protection and having signed a consent form.
- 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
- 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)
- Inclusion criteria for patients with CS: patients with clinical symptoms and imaging suggestive of acute stroke (< 24 hours, NIHSS score >5)
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
QR (relative amount)
Time frame: Up to 3 months after the end of all samplings.
QR (relative amount) of each plasma microRNA for GBM and non-glial tumors (PCNSL, BM).
3 secondary outcomes
QR value of each microRNA for all groups
Time frame: Up to 3 months after the end of all samplings
Genetic abnormalities
Time frame: Up to 3 months after the end of the study
Main imaging and anatomopathology characteristics
Time frame: Up to 3 months after the end of the study
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Tumors, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
QR (relative amount) (time frame: Up to 3 months after the end of all samplings.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2018.