GlioblastomaSWIGLINCT02899663
MRI Detection of Microbleeds in Glioma Patients
An observational study of Glioblastoma, run by Fondation Ophtalmologique Adolphe de Rothschild.
Trial summary
Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioblastoma
- How many people
- 58 participants
- Where
- No sites listed yet
- Study dates
- Jan 2015to Aug 2015
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients suffering from brain glioblastoma
Who may be able to join
- Adult patients
- Diagnosed with brain glioblastoma
- Receiving treatment with cranial radiotherapy and/or chemotherapy
- Having at least one follow-up MRI conducted that used a susceptibility weighted imaging sequence
Who cannot join
- Underage
- Absence of formal diagnosis of glioblastoma
- No available medical imaging file with MRI susceptibility weighted imaging sequence
About this study
Official title: Detection of Microbleeds With MRI (SWI Sequences) in Glioma Patients
Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma.
- Conditions
- Glioblastoma
- Medical subject headings
- Glioblastoma
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of microbleeds diagnosed with MRI (susceptibility weighted imaging sequence)
Measured: At the time of each MRI conducted within 5 years after diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study startJan 2015
- Primary completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlioblastomaStudies of the same condition, open and under way.
- More trials run by Fondation Ophtalmologique Adolphe de RothschildThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Ophtalmologique Adolphe de Rothschild
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899663
- Sponsor's protocol ID
- NI_ALR_2016_1
- Acronym
- SWIGLI
- Status last verified
- Sep 2016
- First submitted
- 9 Sep 2016
- Last updated
- 14 Sep 2016
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detection of Microbleeds With MRI (SWI Sequences) in Glioma Patients
- ClinicalTrials.gov ID
- NCT02899663
- Acronym / sponsor ID
- SWIGLI / NI_ALR_2016_1
- Conditions
- Glioblastoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Fondation Ophtalmologique Adolphe de RothschildResearch network
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- First posted
- 14 Sep 2016 (estimated)
- 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.
Systematic retrospective medical chart and medical imaging file review of all patients receiving brain MRI for the follow-up of glioblastoma.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients suffering from brain glioblastoma
Key inclusion criteria (4 listed)
- Adult patients
- Diagnosed with brain glioblastoma
- Receiving treatment with cranial radiotherapy and/or chemotherapy
- Having at least one follow-up MRI conducted that used a susceptibility weighted imaging sequence
Key exclusion criteria (3 listed)
- Underage
- Absence of formal diagnosis of glioblastoma
- No available medical imaging file with MRI susceptibility weighted imaging sequence
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
Number of microbleeds diagnosed with MRI (susceptibility weighted imaging sequence)
Time frame: At the time of each MRI conducted within 5 years after diagnosis
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 14 Sep 2016.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioblastoma, run by Fondation Ophtalmologique Adolphe de Rothschild.
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 3 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 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Number of microbleeds diagnosed with MRI (susceptibility weighted imaging sequence) (time frame: At the time of each MRI conducted within 5 years after diagnosis). 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 14 Sep 2016.