Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.

August 6, 2019 updated by: Amr Badary, Assiut University
Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

28

Contacts and Locations

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

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

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recurrence or increased residual
Time Frame: within 3 months after treatment
Recurrence of the tumor
within 3 months after treatment

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

  • Study Director: Mahmoud Ragab, Assiut University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

September 1, 2019

Primary Completion (Anticipated)

April 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

June 21, 2019

First Submitted That Met QC Criteria

June 24, 2019

First Posted (Actual)

June 25, 2019

Study Record Updates

Last Update Posted (Actual)

August 7, 2019

Last Update Submitted That Met QC Criteria

August 6, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Brain Gliomas Surgery

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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