Neurocognitive Outcome Assesment in Patients With Perioptic MeningiomasPhase 4NCT03190122
Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
A Phase 4 study testing surgical excision of the tumor in people with Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas, run by Kasr El Aini Hospital.
Trial summary
Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas
- What is being tested?
- surgical excision of the tumor
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- Jun 2017to Apr 2018
- Phase
- Phase 4
- 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 20 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- preoptic meningioma, not recurrent, size is operative.
Who cannot join
- other meningiomas than preoptic , recurrent cases, size is not operative, other medical conditions affect the mental condition of the patient.
About this study
Official title: Neurocognitive Outcome Assessment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
- Being tested
- surgical excision of the tumor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
surgical excision of the tumorProcedure or surgery
Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial. [NCT ID not yet assigned]
| Study group | Role | What they receive |
|---|---|---|
| group with pealing of the outer layer of cavernous sinus | Active comparator | Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Pealing Of The Outer Layer Of The Cavernous Sinus Receives: Procedure: surgical excision of the tumor |
| group without pealing of the outer layer of cavernous sinus | Experimental | Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision Without Pealing Of The Outer Layer Of The Cavernous Sinus Receives: Procedure: surgical excision of the tumor |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neurocognitive Outcome Assessment using MOCA scale
aggregated by our researchers in data base system in our department.
Measured: 1 year
Secondary outcomes (1)
Neurocognitive Outcome using neuropsychological assessment questionnaire
aggregated by our researchers in data base system in our department.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2017
- Study startJun 2017 (estimated)
- Primary completionApr 2018 (estimated)
- Study completionApr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurocognitive Outcome Assesment in Patients With Perioptic MeningiomasStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kasr El Aini Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Hegazy, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03190122
- Sponsor's protocol ID
- N-71-2016
- Status last verified
- Jun 2017
- First submitted
- 10 May 2017
- Last updated
- 16 Jun 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neurocognitive Outcome Assessment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
- ClinicalTrials.gov ID
- NCT03190122
- Acronym / sponsor ID
- N-71-2016
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Kasr El Aini HospitalUniversity, hospital or other
- Study start
- Jun 2017 (estimated)
- Primary completion
- Apr 2018 (estimated)
- Study completion
- Apr 2018 (estimated)
- First posted
- 16 Jun 2017 (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.
Neurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group with pealing of the outer layer of cavernous sinus | Active comparator | Procedure: surgical excision of the tumorNeurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Pealing Of The Outer Layer Of The Cavernous Sinus |
| group without pealing of the outer layer of cavernous sinus | Experimental | Procedure: surgical excision of the tumorNeurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision Without Pealing Of The Outer Layer Of The Cavernous Sinus |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- preoptic meningioma, not recurrent, size is operative.
Key exclusion criteria (1 listed)
- other meningiomas than preoptic , recurrent cases, size is not operative, other medical conditions affect the mental condition of the patient.
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 |
|---|---|---|
| surgical excision of the tumorNeurocognitive Outcome Assesment in Patients With Peri-optic Meningiomas After Excision With Or Without Pealing Of The Outer Layer Of The Cavernous Sinus: A Randomized Controlled Single Blinded Trial. [NCT ID not yet assigned] | Procedure or surgery | group with pealing of the outer layer of cavernous sinus, group without pealing of the outer layer of cavernous sinus |
Primary outcome
Neurocognitive Outcome Assessment using MOCA scale
Time frame: 1 year
aggregated by our researchers in data base system in our department.
1 secondary outcome
Neurocognitive Outcome using neuropsychological assessment questionnaire
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2017.
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?
A Phase 4 study testing surgical excision of the tumor in people with Neurocognitive Outcome Assesment in Patients With Perioptic Meningiomas, run by Kasr El Aini Hospital.
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 16 Jun 2017. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
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?
Neurocognitive Outcome Assessment using MOCA scale (time frame: 1 year). 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 Jun 2017.