Supratentorial GlioblastomaNCT03997136
Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
An observational study of Supratentorial Glioblastoma, run by Assiut University.
Trial summary
Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Supratentorial Glioblastoma
- What is being tested?
- Supratentorial high grade gliomas resection.
- Type of treatment
- Surgery or procedure
- How many people
- 28 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2019to 1 Jul 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: All cases of patients of supratentorial high grade gliomas that fullfill the selection criteria that will be admitted in the department of neurosurgery in Assuit university hospital. (Non propability sample size) with expected size of 28 patients starting from 01/07/2019 to 15/06/2021. Patients whose follow-ups will be lost due to any other cause will be excluded from this study (expected to be 25%). Additionally, the competence of follow-up will be approved by imaging and medical records.
Who may be able to join
- Patients who will undergo surgical excision of the supratentorial high grade gliomas at the time of study (two years).
- Denovo disease for the first time.
- Any age
Who cannot join
- Low-grade Gliomas.
- Infratentorial high-grade gliomas.
- Past history of gliomas.
- Patients who are unfit for any neurosurgical interventions.
- Patients who do not receive their adjuvant standard therapy.
Trial locations and contacts
No sites are listed yet.
About this study
Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.
Read the detailed description
Supratentorial high grade gliomas are for surgical resection in any case according to many factors.
Investigators will compare the outcomes/survival rate and clinical outcome of the different resection types (Total, near total, subtotal/debulking) of supratentorial high grade gliomas according to the clinical condition and comorbidities of the patient, the location and morphology of the lesion, the grading of lesions, and the clinical experience of the neurosurgeon.
- Conditions
- Supratentorial Glioblastoma
- Being tested
- Supratentorial high grade gliomas resection.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supratentorial high grade gliomas resection.Procedure or surgery
Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical picture using Modified Rankin's Scale (mRS).
The changes in clinical condition of the patients will be assessed using Modified Rankin's Scale (mRS) before and after treatment.
The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms.
- - No significant disability. Able to carry out all usual activities, despite some symptoms.
- - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities.
- - Moderate disability. Requires some help, but able to walk unassisted.
- - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted.
- - Severe disability. Requires constant nursing care and attention, bedridden, incontinent.
- - Dead.
Measured: 1 year
Secondary outcomes (1)
Recurrence or increased residual
Recurrence of the tumor
Measured: within 3 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2019
- Study start1 Sep 2019 (estimated)
- Primary completion1 Apr 2021 (estimated)
- Study completion1 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Supratentorial GlioblastomaStudies 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
- 28 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Badary, Assiut University
- Investigators
- Mahmoud Ragab, Study director, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03997136
- Sponsor's protocol ID
- Brain Gliomas Surgery
- Status last verified
- Aug 2019
- First submitted
- 21 Jun 2019
- Last updated
- 7 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gulati S, Jakola AS, Nerland US, Weber C, Solheim O. The risk of getting worse: surgically acquired deficits, perioperative complications, and functional outcomes after primary resection of glioblastoma. World Neurosurg. 2011 Dec;76(6):572-9. doi: 10.1016/j.wneu.2011.06.014.
PubMed 22251506Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.
PubMed 24842956Ryken TC, Frankel B, Julien T, Olson JJ. Surgical management of newly diagnosed glioblastoma in adults: role of cytoreductive surgery. J Neurooncol. 2008 Sep;89(3):271-86. doi: 10.1007/s11060-008-9614-5. Epub 2008 Aug 20. No abstract available.
PubMed 18712281Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011 Jul;115(1):3-8. doi: 10.3171/2011.2.jns10998. Epub 2011 Mar 18.
PubMed 21417701Orringer D, Lau D, Khatri S, Zamora-Berridi GJ, Zhang K, Wu C, Chaudhary N, Sagher O. Extent of resection in patients with glioblastoma: limiting factors, perception of resectability, and effect on survival. J Neurosurg. 2012 Nov;117(5):851-9. doi: 10.3171/2012.8.JNS12234. Epub 2012 Sep 14.
PubMed 22978537
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
- ClinicalTrials.gov ID
- NCT03997136
- Acronym / sponsor ID
- Brain Gliomas Surgery
- Conditions
- Supratentorial Glioblastoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 28 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 1 Apr 2021 (estimated)
- Study completion
- 1 Jul 2021 (estimated)
- First posted
- 25 Jun 2019 (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.
Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.
Detailed description
Supratentorial high grade gliomas are for surgical resection in any case according to many factors.
Investigators will compare the outcomes/survival rate and clinical outcome of the different resection types (Total, near total, subtotal/debulking) of supratentorial high grade gliomas according to the clinical condition and comorbidities of the patient, the location and morphology of the lesion, the grading of lesions, and the clinical experience of the neurosurgeon.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases of patients of supratentorial high grade gliomas that fullfill the selection criteria that will be admitted in the department of neurosurgery in Assuit university hospital. (Non propability sample size) with expected size of 28 patients starting from 01/07/2019 to 15/06/2021. Patients whose follow-ups will be lost due to any other cause will be excluded from this study (expected to be 25%). Additionally, the competence of follow-up will be approved by imaging and medical records.
Key inclusion criteria (3 listed)
- Patients who will undergo surgical excision of the supratentorial high grade gliomas at the time of study (two years).
- Denovo disease for the first time.
- Any age
Key exclusion criteria (5 listed)
- Low-grade Gliomas.
- Infratentorial high-grade gliomas.
- Past history of gliomas.
- Patients who are unfit for any neurosurgical interventions.
- Patients who do not receive their adjuvant standard therapy.
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 |
|---|---|---|
| Supratentorial high grade gliomas resection.Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas | Procedure or surgery | – |
Primary outcome
Clinical picture using Modified Rankin's Scale (mRS).
Time frame: 1 year
The changes in clinical condition of the patients will be assessed using Modified Rankin's Scale (mRS) before and after treatment. The scale runs from 0-6, running from perfect health without symptoms to death. 0 - No symptoms. 1. - No significant disability. Able to carry out all usual activities, despite some symptoms. 2. - Slight disability. Able to look after own affairs without assistance, but unable to carry out all previous activities. 3. - Moderate disability. Requires some help, but able to walk unassisted. 4. - Moderately severe disability. Unable to attend to own bodily needs without assistance, and unable to walk unassisted. 5. - Severe disability. Requires constant nursing care and attention, bedridden, incontinent. 6. - Dead.
1 secondary outcome
Recurrence or increased residual
Time frame: within 3 months after treatment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Aug 2019.
- Background: PubMed 22251506Gulati S, Jakola AS, Nerland US, Weber C, Solheim O. The risk of getting worse: surgically acquired deficits, perioperative complications, and functional outcomes after primary resection of glioblastoma. World Neurosurg. 2011 Dec;76(6):572-9. doi: 10.1016/j.wneu.2011.06.014.
- Background: PubMed 24842956Ostrom QT, Bauchet L, Davis FG, Deltour I, Fisher JL, Langer CE, Pekmezci M, Schwartzbaum JA, Turner MC, Walsh KM, Wrensch MR, Barnholtz-Sloan JS. The epidemiology of glioma in adults: a "state of the science" review. Neuro Oncol. 2014 Jul;16(7):896-913. doi: 10.1093/neuonc/nou087.
- Background: PubMed 18712281Ryken TC, Frankel B, Julien T, Olson JJ. Surgical management of newly diagnosed glioblastoma in adults: role of cytoreductive surgery. J Neurooncol. 2008 Sep;89(3):271-86. doi: 10.1007/s11060-008-9614-5. Epub 2008 Aug 20. No abstract available.
- Background: PubMed 21417701Sanai N, Polley MY, McDermott MW, Parsa AT, Berger MS. An extent of resection threshold for newly diagnosed glioblastomas. J Neurosurg. 2011 Jul;115(1):3-8. doi: 10.3171/2011.2.jns10998. Epub 2011 Mar 18.
- Background: PubMed 22978537Orringer D, Lau D, Khatri S, Zamora-Berridi GJ, Zhang K, Wu C, Chaudhary N, Sagher O. Extent of resection in patients with glioblastoma: limiting factors, perception of resectability, and effect on survival. J Neurosurg. 2012 Nov;117(5):851-9. doi: 10.3171/2012.8.JNS12234. Epub 2012 Sep 14.
Related trials for Supratentorial Glioblastoma
RecruitingEarly Phase 1
Pilot Study Evaluating Panitumumab-IRDye800 as an Optical Imaging Agent to Detect Intracranial Lesions During Neurosurgical Procedures
Meningioma, Glioblastoma
Active, not recruitingPhase 2
Pembrolizumab and Standard Therapy in Treating Patients With Glioblastoma
Glioblastoma, Gliosarcoma
RecruitingPhase 2
hSTAR GBM (Hematopoetic Stem Cell (HPC) Rescue for GBM)
Glioblastoma Multiforme, Glioblastoma Multiforme, Adult
RecruitingPhase 1
Phase I CB-NK-TGF-ßR2-/NR3C1- in rGBM
Recurrent Gliosarcoma, Recurrent Supratentorial Glioblastoma
RecruitingPhase 2
Lerapolturev (PVSRIPO) in GBM
Recurrent Supratentorial Glioblastoma
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.
Mahmoud Ragab study director
Assiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Supratentorial Glioblastoma, 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 3 inclusion and 5 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 7 Aug 2019. 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 Amr Badary (00201023310102 ext. 00201023310102, amr.badary@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical picture using Modified Rankin's Scale (mRS). (time frame: 1 year). 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 NCT03997136, which also lists 5 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 7 Aug 2019.