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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03997136
Recruitment Status : Not yet recruiting
First Posted : June 25, 2019
Last Update Posted : August 7, 2019
Sponsor:
Information provided by (Responsible Party):
Amr Badary, Assiut University

Brief Summary:
Prospective randomized controlled clinical trials (single arm study) of surgical treatment modalities for supratentorial high grade gliomas within the next two years.

Condition or disease Intervention/treatment
Supratentorial Glioblastoma Procedure: Supratentorial high grade gliomas resection.

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.

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Study Type : Observational
Estimated Enrollment : 28 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
Estimated Study Start Date : September 1, 2019
Estimated Primary Completion Date : April 1, 2021
Estimated Study Completion Date : July 1, 2021

Resource links provided by the National Library of Medicine



Intervention Details:
  • Procedure: Supratentorial high grade gliomas resection.
    Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas


Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Recurrence or increased residual [ Time Frame: within 3 months after treatment ]
    Recurrence of the tumor



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03997136


Contacts
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Contact: Amr Badary 00201023310102 ext 00201023310102 amr.badary@hotmail.com
Contact: Abdelhakeem Abdelhakeem 00201023310102 ext 00201023310102 amr.badary@hotmail.com

Sponsors and Collaborators
Assiut University
Investigators
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Study Director: Mahmoud Ragab Assiut University
Publications:
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Responsible Party: Amr Badary, Resident Doctor, Assiut University
ClinicalTrials.gov Identifier: NCT03997136    
Other Study ID Numbers: Brain Gliomas Surgery
First Posted: June 25, 2019    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Glioblastoma
Astrocytoma
Glioma
Neoplasms, Neuroepithelial
Neuroectodermal Tumors
Neoplasms, Germ Cell and Embryonal
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Glandular and Epithelial
Neoplasms, Nerve Tissue