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出境医 / 临床实验 / Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.

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

Study Description
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.

Study Design
Layout table for study information
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
Arms and Interventions
Outcome Measures
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


Eligibility Criteria
Contacts and Locations
Tracking Information
First Submitted Date June 21, 2019
First Posted Date June 25, 2019
Last Update Posted Date August 7, 2019
Estimated Study Start Date September 1, 2019
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 24, 2019) 		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.
Original Primary Outcome Measures
 (submitted: June 24, 2019) 		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
Change History
Current Secondary Outcome Measures
 (submitted: June 24, 2019) 		Recurrence or increased residual [ Time Frame: within 3 months after treatment ]
Recurrence of the tumor
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
Official Title Prognostic Impact of Surgical Resection Extent for Supratentorial High Grade Gliomas.
Brief Summary 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 Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Supratentorial Glioblastoma
Intervention Procedure: Supratentorial high grade gliomas resection.
Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas
Study Groups/Cohorts Not Provided
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.
  • Ostrom 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. Review.
  • Ryken 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.
  • Sanai 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.
  • Orringer 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Not yet recruiting
Estimated Enrollment
 (submitted: June 24, 2019) 		28
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 1, 2021
Estimated Primary Completion Date April 1, 2021   (Final data collection date for primary outcome measure)
Eligibility 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.
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Amr Badary 00201023310102 ext 00201023310102 amr.badary@hotmail.com
Contact: Abdelhakeem Abdelhakeem 00201023310102 ext 00201023310102 amr.badary@hotmail.com
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03997136
Other Study ID Numbers Brain Gliomas Surgery
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Amr Badary, Assiut University
Study Sponsor Assiut University
Collaborators Not Provided
Investigators
Study Director: Mahmoud Ragab Assiut University
PRS Account Assiut University
Verification Date August 2019

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