Low Grade Glioma of BrainNCT06499922
Surgical Management of Low Grade Glioma
An observational study of Low Grade Glioma of Brain, run by Assiut University.
Trial summary
To assess the morbidity and mortality in low grade glioma patients following surgical management. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Low Grade Glioma of Brain
- What is being tested?
- SURGICAL EXCISION
- Type of treatment
- Surgery or procedure
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- Aug 2024to 1 Jul 2026
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Each patient will be subjected to: * A complete history including personal history, history of seizures or drug intake. * General clinical examination. * Neurological examination.
Who may be able to join
- Patients diagnosed radiologically with low grade glioma
Who cannot join
- patients not fit for surgery
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Recent Advances in Surgical Management of Low Grade Glioma
To assess the morbidity and mortality in low grade glioma patients following surgical management.
Read the detailed description
lower-grade gliomas histological diagnosis has had a long history, each iteration of disease classification suffered from continued variability, with detrimental consequences on prognostic precision and treatment decision making.
In the WHO 2021 classification, there are three primary categories of adult-type diffuse gliomas: isocitrate dehydrogenase (IDH)-mutant, 1p/19q codeleted oligodendroglioma; IDH-mutant, non-codeleted astrocytoma; and IDH-wildtype glioblastoma. Diffuse low-grade glioma is classified as WHO grade 1 and 2 astrocytoma with IDH mutation or oligodendroglioma with IDH mutation and 1p/19q codeletion.
The presence of the IDH1 mutation has become a defining factor for adult diffuse low-grade glioma. Roughly 70% of grade 2-3 gliomas harbor mutations in either IDH1 or its mitochondrial counterpart IDH2.
Although lower-grade gliomas may present in various ways, the most common manifestation is seizures, and the development of seizures during the course of the disease may herald tumor progression. Among grade II tumors, the incidence of epilepsy is higher with IDH mutation. Anaplastic gliomas are somewhat less likely to manifest with seizures (57%) and are more likely than grade II gliomas to produce mental status, vision, and motor deficits.
- Conditions
- Low Grade Glioma of Brain
- Being tested
- SURGICAL EXCISION
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SURGICAL EXCISIONProcedure or surgery
surgical excision of low grade glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Morbidity in low grade glioma patients following surgical management.
report THE RATE OF POSTOPERATIVE MORBIDITY Among participants using the neurological condition assessment ( kornofisky Scale).
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2024
- Study startAug 2024 (estimated)
- Primary completionMar 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Low Grade Glioma of BrainStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, M.Hossam Mohammad, Assiut University
- Investigators
- Ahmed El Gheriani, professor, Study chair, professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06499922
- Sponsor's protocol ID
- Surgery of low grade glioma
- Status last verified
- Jul 2024
- First submitted
- 31 May 2024
- Last updated
- 15 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Davis ME. Epidemiology and Overview of Gliomas. Semin Oncol Nurs. 2018 Dec;34(5):420-429. doi: 10.1016/j.soncn.2018.10.001. Epub 2018 Nov 2.
PubMed 30392758Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.
PubMed 34185076Mazzucchi E, La Rocca G, Ius T, Sabatino G, Della Pepa GM. Multimodality Imaging Techniques to Assist Surgery in Low-Grade Gliomas. World Neurosurg. 2020 Jan;133:423-425. doi: 10.1016/j.wneu.2019.10.120. No abstract available.
PubMed 31881559
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recent Advances in Surgical Management of Low Grade Glioma
- ClinicalTrials.gov ID
- NCT06499922
- Acronym / sponsor ID
- Surgery of low grade glioma
- Conditions
- Low Grade Glioma of Brain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Aug 2024 (estimated)
- Primary completion
- Mar 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 15 Jul 2024 (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.
To assess the morbidity and mortality in low grade glioma patients following surgical management.
Detailed description
lower-grade gliomas histological diagnosis has had a long history, each iteration of disease classification suffered from continued variability, with detrimental consequences on prognostic precision and treatment decision making.
In the WHO 2021 classification, there are three primary categories of adult-type diffuse gliomas: isocitrate dehydrogenase (IDH)-mutant, 1p/19q codeleted oligodendroglioma; IDH-mutant, non-codeleted astrocytoma; and IDH-wildtype glioblastoma. Diffuse low-grade glioma is classified as WHO grade 1 and 2 astrocytoma with IDH mutation or oligodendroglioma with IDH mutation and 1p/19q codeletion.
The presence of the IDH1 mutation has become a defining factor for adult diffuse low-grade glioma. Roughly 70% of grade 2-3 gliomas harbor mutations in either IDH1 or its mitochondrial counterpart IDH2.
Although lower-grade gliomas may present in various ways, the most common manifestation is seizures, and the development of seizures during the course of the disease may herald tumor progression. Among grade II tumors, the incidence of epilepsy is higher with IDH mutation. Anaplastic gliomas are somewhat less likely to manifest with seizures (57%) and are more likely than grade II gliomas to produce mental status, vision, and motor deficits.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Each patient will be subjected to: * A complete history including personal history, history of seizures or drug intake. * General clinical examination. * Neurological examination.
Key inclusion criteria (1 listed)
- Patients diagnosed radiologically with low grade glioma
Key exclusion criteria (1 listed)
- patients not fit for surgery
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 EXCISIONsurgical excision of low grade glioma | Procedure or surgery | – |
Primary outcome
Morbidity in low grade glioma patients following surgical management.
Time frame: 2 years
report THE RATE OF POSTOPERATIVE MORBIDITY Among participants using the neurological condition assessment ( kornofisky Scale).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jul 2024.
- Background: PubMed 30392758Davis ME. Epidemiology and Overview of Gliomas. Semin Oncol Nurs. 2018 Dec;34(5):420-429. doi: 10.1016/j.soncn.2018.10.001. Epub 2018 Nov 2.
- Background: PubMed 34185076Louis DN, Perry A, Wesseling P, Brat DJ, Cree IA, Figarella-Branger D, Hawkins C, Ng HK, Pfister SM, Reifenberger G, Soffietti R, von Deimling A, Ellison DW. The 2021 WHO Classification of Tumors of the Central Nervous System: a summary. Neuro Oncol. 2021 Aug 2;23(8):1231-1251. doi: 10.1093/neuonc/noab106.
- Background: PubMed 31881559Mazzucchi E, La Rocca G, Ius T, Sabatino G, Della Pepa GM. Multimodality Imaging Techniques to Assist Surgery in Low-Grade Gliomas. World Neurosurg. 2020 Jan;133:423-425. doi: 10.1016/j.wneu.2019.10.120. No abstract available.
- Individual participant dataSharing planned: No
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Low-grade Glioma
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.
Ahmed El Gheriani, professor study chair
professor
Questions about this trial
What is this clinical trial studying?
An observational study of Low Grade Glioma of Brain, 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 15 Jul 2024. 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 Mohammad Hossam, master (201005663647, mohammadhossam74@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Morbidity in low grade glioma patients following surgical management. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06499922, which also lists 3 linked publications.
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 Jul 2024.