Brain MeningiomaNCT04710485
Sphenoorbital Meningioma Management.
An observational study of Brain Meningioma, run by Assiut University.
Trial summary
Investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours. Read more about this study
- Who is it for?
- Ages 5 to 90 years
- Conditions the study is for
- Brain Meningioma
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 30 Jan 2021to 1 Jan 2023
- 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 5 to 90 years
- All sexes
- Child, Adult, Older adult
Study population: Any patient candidate for surgery will be included in our study.
Who may be able to join
- all patients who have spheno_orbital meningioma with proptosis and candidate for surgery.
Who cannot join
- all patients have proptosis caused by other lesions than spheno_orbital meningioma.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Spheno_orbital Meningioma Enplaque With Proptosis; Surgical Techniques and Outcomes
Investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.
- Conditions
- Brain Meningioma
- Medical subject headings
- Meningioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical assessment for vision.
With visual acuity examination
Measured: For 6 months
Clinical assessment for proptosis
With proptosis index
Measured: For 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2021
- Study start30 Jan 2021 (estimated)
- Primary completion20 Dec 2022 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain MeningiomaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe 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
- Other
- Time perspective
- Prospective
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa metwally kashef ali, Assiut University
- Investigators
- Assiut Au University, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04710485
- Sponsor's protocol ID
- Mng
- Status last verified
- Jan 2021
- First submitted
- 12 Jan 2021
- Last updated
- 14 Jan 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 14 Jan 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spheno_orbital Meningioma Enplaque With Proptosis; Surgical Techniques and Outcomes
- ClinicalTrials.gov ID
- NCT04710485
- Acronym / sponsor ID
- Mng
- Conditions
- Brain Meningioma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 30 Jan 2021 (estimated)
- Primary completion
- 20 Dec 2022 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 14 Jan 2021 (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.
Investigators will discuss the different surgical techniques for removal of spheno_orbital meningiomas with proptosis.investigators also will follow up the patient to know the outcome of removal of these tumours.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 5 to 90 years
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Any patient candidate for surgery will be included in our study.
Key inclusion criteria (1 listed)
- all patients who have spheno_orbital meningioma with proptosis and candidate for surgery.
Key exclusion criteria (1 listed)
- all patients have proptosis caused by other lesions than spheno_orbital meningioma.
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
Clinical assessment for vision.
Time frame: For 6 months
With visual acuity examination
Clinical assessment for proptosis
Time frame: For 6 months
With proptosis index
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jan 2021.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Meningioma
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
RecruitingPhase 2
Vismodegib, FAK Inhibitor GSK2256098, Capivasertib, and Abemaciclib in Treating Patients With Progressive Meningiomas
Intracranial Meningioma, Recurrent Meningioma
RecruitingPhase 4
68-Ga DOTATATE PET/MRI in the Diagnosis and Management of Somatostatin Receptor Positive CNS Tumors.
CNS Tumors, Meningioma
RecruitingPhase 2
A Study of Zanzalintinib in Participants With Recurrent or Progressive Meningioma
Meningioma
Active, not recruitingPhase 2
Enhancement of Neurocognitive Functions by Hippocampal Sparing Radiotherapy
Radiation of Neurocranial Region
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.
Assiut Au University principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Brain Meningioma, run by Assiut University.
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 1 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: status not confirmed, as of the sponsor's last update on 14 Jan 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa Mk Kashef, Assistant lecturer (01012962093, mostafakashef99@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical assessment for vision. (time frame: For 6 months). The study lists 2 primary outcomes in all. 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 Jan 2021.