NCT03997136

Brief Summary

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

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
28

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Sep 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 21, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 25, 2019

Completed
2 months until next milestone

Study Start

First participant enrolled

September 1, 2019

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2021

Completed
Last Updated

August 7, 2019

Status Verified

August 1, 2019

Enrollment Period

1.6 years

First QC Date

June 21, 2019

Last Update Submit

August 6, 2019

Conditions

Supratentorial Glioblastoma

Outcome Measures

Primary Outcomes (1)

  • Clinical picture using Modified Rankin's Scale (mRS).

    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 Outcomes (1)

  • Recurrence or increased residual

    within 3 months after treatment

Interventions

Supratentorial high grade gliomas resection.PROCEDURE

Total, near total or subtotal/debulking resection of the brain supratentorial high grade gliomas

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (5)

  • 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.

    PMID: 22251506BACKGROUND

  • 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. doi: 10.1093/neuonc/nou087.

    PMID: 24842956BACKGROUND

  • 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. No abstract available.

    PMID: 18712281BACKGROUND

  • 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.

    PMID: 21417701BACKGROUND

  • 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.

    PMID: 22978537BACKGROUND

Study Officials

  • Mahmoud Ragab

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Amr Badary

CONTACT

00201023310102amr.badary@hotmail.com

Abdelhakeem Abdelhakeem

CONTACT

00201023310102amr.badary@hotmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident Doctor

Study Record Dates

First Submitted

June 21, 2019

First Posted

June 25, 2019

Study Start

September 1, 2019

Primary Completion

April 1, 2021

Study Completion

July 1, 2021

Last Updated

August 7, 2019

Record last verified: 2019-08