Low-grade GliomaSPECIFYNCT04346472
Longitudinal MRI Assessment in Patients With Diffuse Low-grade Gliomas
An observational study of Low-grade Glioma, run by University Hospital, Montpellier at 1 site in France.
Trial summary
Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low-grade Glioma
- What is being tested?
- Repeated Measurements of the relative regional cerebral blood volume
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Mar 2016to 30 Jan 2020
- 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: Patients with diffuse low-grade glioma (WHO grade II)
Who may be able to join
- Initial WHO grade II
- At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging
Who cannot join
- -Major protected person ( trusteeship, curatorship, justice safeguard)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment
Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment
- Conditions
- Low-grade Glioma
- Being tested
- Repeated Measurements of the relative regional cerebral blood volume
- Keywords
- Glioma, Magnetic Resonance Imaging, Magnetic Resonance Angiography, Disease Progression, Supratentorial Neoplasms, Blood Volume, Contrast Media, Gadolinium DTPA, Image Processing, Computer-Assisted, Neovascularization, Pathologic, Diffuse low grade glioma, Relative regional cerebral blood volume ( rRCBV), Early prognosis of anaplasic transformation, Diffuse low grade glioma anaplasic transformation
- Medical subject headings
- Glioma, Disease Progression, Supratentorial Neoplasms, Neovascularization, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Repeated Measurements of the relative regional cerebral blood volumeOther
Repeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use.
| Study group | Role | What they receive |
|---|---|---|
| Gliomes de grade II initial | Gliomes de grade II initial Receives: Other: Repeated Measurements of the relative regional cerebral blood volume |
What is being measured
The primary outcome is the main question the study is designed to answer.
Longitudinal variation of the relative regional cerebral blood volume
Longitudinal variation of the relative regional cerebral blood volume from first pass perfusion imaging data for each MRI performed
Measured: 1 day
Secondary outcomes (3)
Collection of histological
Collection of histological
Measured: 1 day
Collection of radiological
Collection of radiological
Measured: 1 day
Collection of clinical varaibles
Collection of clinical varaibles
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2020
- Study start1 Mar 2016
- Primary completion30 Dec 2019
- Study completion30 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low-grade GliomaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe 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
- Retrospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nicolas MENJOT DE CHAMPFLEUR, MD, PhD, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04346472
- Sponsor's protocol ID
- UF9647
- Acronym
- SPECIFY
- Status last verified
- Apr 2020
- First submitted
- 10 Apr 2020
- Last updated
- 16 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: NC
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Retrospective Longitudinal Follow-up in Patients With Diffuse Low-grade Glioma With Multimodal MRI Assessment
- ClinicalTrials.gov ID
- NCT04346472
- Acronym / sponsor ID
- SPECIFY / UF9647
- Conditions
- Low-grade Glioma
- Keywords
- Glioma, Magnetic Resonance Imaging, Magnetic Resonance Angiography, Disease Progression, Supratentorial Neoplasms, Blood Volume, Contrast Media, Gadolinium DTPA
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 1 Mar 2016 (actual)
- Primary completion
- 30 Dec 2019 (actual)
- Study completion
- 30 Jan 2020 (actual)
- First posted
- 15 Apr 2020 (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.
Retrospective longitudinal follow-up in patients with diffuse low-grade glioma with multimodal MRI assessment
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Gliomes de grade II initial | – | Other: Repeated Measurements of the relative regional cerebral blood volumeGliomes de grade II initial |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with diffuse low-grade glioma (WHO grade II)
Key inclusion criteria (2 listed)
- Initial WHO grade II
- At least 3 exploitable MRI each including a morphologic FLAIR sequence and perfusion imaging
Key exclusion criteria (1 listed)
- -Major protected person ( trusteeship, curatorship, justice safeguard)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Repeated Measurements of the relative regional cerebral blood volumeRepeated Measurements of the relative regional cerebral blood volume variation through an every 6 monts Magnetic Resonance Imaging use. | Other | Gliomes de grade II initial |
Primary outcome
Longitudinal variation of the relative regional cerebral blood volume
Time frame: 1 day
Longitudinal variation of the relative regional cerebral blood volume from first pass perfusion imaging data for each MRI performed
3 secondary outcomes
Collection of histological
Time frame: 1 day
Collection of radiological
Time frame: 1 day
Collection of clinical varaibles
Time frame: 1 day
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 16 Apr 2020.
- Individual participant dataSharing planned: Undecided. NC
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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.
Nicolas MENJOT DE CHAMPFLEUR, MD, PhD principal investigator
University Hospital, Montpellier
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 Low-grade Glioma, run by University Hospital, Montpellier 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 2 inclusion and 1 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 16 Apr 2020. 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?
Longitudinal variation of the relative regional cerebral blood volume (time frame: 1 day). 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 16 Apr 2020.