Role of Surgery in Treatment of Recurrent Brian Glioma:Prognostic Factors and Outcome

September 18, 2020 updated by: Mohamad Sayed Mohamad, Assiut University

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

- 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.

Exclusion Criteria:

  • patients has brain glioma that is de novo patients who are unfit for any neurosurgical interventions. Multicentric recurrent glioma.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Investigators

  • Study Director: Ahmed AlGhriany, phD, professor of neurosurgery assiut university
  • Study Director: Ahmed AlShanawany, phD, assistant professor of neurosurgery assiut university
  • Principal Investigator: Mohamad S Waer, Resident at department of neurosurgery

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

October 1, 2020

Primary Completion (Anticipated)

November 1, 2021

Study Completion (Anticipated)

November 1, 2021

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

September 18, 2020

First Posted (Actual)

September 24, 2020

Study Record Updates

Last Update Posted (Actual)

September 24, 2020

Last Update Submitted That Met QC Criteria

September 18, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • surgery in glioma

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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