Recurrent GliomaNCT04562077
Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome
An observational study of Recurrent Glioma and Glioma, Malignant, run by Assiut University at 1 site in Egypt.
Trial summary
role of surgery in treatment of recurrent brain glioma prognostic factors and outcome measures Role of surgery : In patients with Grade I gliomas, such as pilocytic astrocytomas, resection is potentially curative. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Recurrent Glioma, Glioma, Malignant
- How many people
- 25 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2020to Nov 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 that fullfill the selection criteria that will be admitted in the department of neurosurgery Assuit university hospital 01/11/2020 to 30/10/2021. Sample size was calculated using Epi- Info7. The previous study reported that, percentage of complications after re-operation in recurrent glioma was 65%. Based on this percentage and with a confidence limits of 10% and a confidence level of 80%, the minimum sample needed for the study was estimated to be 20 patients. Patients whose follow-ups will be lost because of death or 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
- Patient previously operated and documented as a glioma with clinical and neuroimaging and pathological evidences.
- Patients who will undergo re-operation for treatment of a recurrent brain glioma at the time of study(one year) Histological types : Different histological types of glioma.
Who cannot join
- patients has brain glioma that is de novo patients who are unfit for any neurosurgical interventions. Multicentric recurrent glioma.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assuit University Hospitals
Asyut
Mohamad S Waer, 00201066479705, mohamadswaer@icloud.com
About this study
role of surgery in treatment of recurrent brain glioma prognostic factors and outcome measures Role of surgery : In patients with Grade I gliomas, such as pilocytic astrocytomas, resection is potentially curative.
For more diffuse invasive gliomas (Grade II or higher), initial management typically includes maximal safe resection when possible.
Read more
Increasing evidence supports an association between extent of resection and prolonged progression-free and overall survival for patients with diffuse gliomas of all types and grades Many studies reported that more that 90%of patients with glioma showed recurrence at the orginal tumor location.
Review the outcomes of re-operation in treatment of recurrent brain gliomas To determine the prognostic factors which can predict which patient would benefit from multiple surgery .
Trail to Improve the outcome of these patients and decrease rate of complications
- Conditions
- Recurrent Glioma, Glioma, Malignant
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
karnofsky performance status
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient could be included in a clinical trial. Also called KPS.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2020
- Study startOct 2020 (estimated)
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Recurrent GliomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamad Sayed Mohamad, Assiut University
- Investigators
- Ahmed AlGhriany, phD, Study director, professor of neurosurgery assiut universityAhmed AlShanawany, phD, Study director, assistant professor of neurosurgery assiut universityMohamad S Waer, Principal investigator, Resident at department of neurosurgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04562077
- Sponsor's protocol ID
- surgery in glioma
- Status last verified
- Sep 2020
- First submitted
- 18 Sep 2020
- Last updated
- 24 Sep 2020
- Results posted
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome
- ClinicalTrials.gov ID
- NCT04562077
- Acronym / sponsor ID
- surgery in glioma
- Conditions
- Recurrent Glioma, Glioma, Malignant
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2020 (estimated)
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 24 Sep 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.
role of surgery in treatment of recurrent brain glioma prognostic factors and outcome measures Role of surgery : In patients with Grade I gliomas, such as pilocytic astrocytomas, resection is potentially curative.
For more diffuse invasive gliomas (Grade II or higher), initial management typically includes maximal safe resection when possible.
Increasing evidence supports an association between extent of resection and prolonged progression-free and overall survival for patients with diffuse gliomas of all types and grades Many studies reported that more that 90%of patients with glioma showed recurrence at the orginal tumor location.
Review the outcomes of re-operation in treatment of recurrent brain gliomas To determine the prognostic factors which can predict which patient would benefit from multiple surgery .
Trail to Improve the outcome of these patients and decrease rate of complications
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All cases that fullfill the selection criteria that will be admitted in the department of neurosurgery Assuit university hospital 01/11/2020 to 30/10/2021. Sample size was calculated using Epi- Info7. The previous study reported that, percentage of complications after re-operation in recurrent glioma was 65%. Based on this percentage and with a confidence limits of 10% and a confidence level of 80%, the minimum sample needed for the study was estimated to be 20 patients. Patients whose follow-ups will be lost because of death or 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 (2 listed)
- Patient previously operated and documented as a glioma with clinical and neuroimaging and pathological evidences.
- Patients who will undergo re-operation for treatment of a recurrent brain glioma at the time of study(one year) Histological types : Different histological types of glioma.
Key exclusion criteria (1 listed)
- patients has brain glioma that is de novo patients who are unfit for any neurosurgical interventions. Multicentric recurrent glioma.
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
karnofsky performance status
Time frame: 1year
A standard way of measuring the ability of cancer patients to perform ordinary tasks. The Karnofsky Performance Status scores range from 0 to 100. A higher score means the patient is better able to carry out daily activities. Karnofsky Performance Status may be used to determine a patient's prognosis, to measure changes in a patient's ability to function, or to decide if a patient could be included in a clinical trial. Also called KPS.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Sep 2020.
- Individual participant dataSharing planned: Undecided
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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.
Ahmed AlGhriany, phD study director
professor of neurosurgery assiut university
Ahmed AlShanawany, phD study director
assistant professor of neurosurgery assiut university
Mohamad S Waer principal investigator
Resident at department of neurosurgery
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 Recurrent Glioma and Glioma, Malignant, run by Assiut University at 1 site in Egypt.
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: status not confirmed, as of the sponsor's last update on 24 Sep 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mohamad S Waer (00201066479705, mohamadswaer@icloud.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
karnofsky performance status (time frame: 1year). 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 24 Sep 2020.