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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages N/A and Over
Gender All
More Inclusion & Exclusion 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03997136
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Assiut University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Mahmoud Ragab
Principal Investigator Affiliation Assiut University
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Unknown status
Countries
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Supratentorial Glioblastoma
Additional Details

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.

Contact Information

This trial has no sites locations listed at this time. If you are interested in learning more, you can contact the trial's primary contact:

Amr Badary

[email protected]

00201023310102

For additional contact information, you can also visit the trial on clinicaltrials.gov.