SURGICAL EXCISION in Low Grade Glioma of Brain - Clinical Trials Registry

Study Overview

Status

Not yet recruiting

Conditions

Low Grade Glioma of Brain

Intervention / Treatment

Procedure: SURGICAL EXCISION

Detailed Description

lower-grade gliomas histological diagnosis has had a long history, each iteration of disease classification suffered from continued variability, with detrimental consequences on prognostic precision and treatment decision making.

In the WHO 2021 classification, there are three primary categories of adult-type diffuse gliomas: isocitrate dehydrogenase (IDH)-mutant, 1p/19q codeleted oligodendroglioma; IDH-mutant, non-codeleted astrocytoma; and IDH-wildtype glioblastoma. Diffuse low-grade glioma is classified as WHO grade 1 and 2 astrocytoma with IDH mutation or oligodendroglioma with IDH mutation and 1p/19q codeletion.

The presence of the IDH1 mutation has become a defining factor for adult diffuse low-grade glioma. Roughly 70% of grade 2-3 gliomas harbor mutations in either IDH1 or its mitochondrial counterpart IDH2.

Although lower-grade gliomas may present in various ways, the most common manifestation is seizures, and the development of seizures during the course of the disease may herald tumor progression. Among grade II tumors, the incidence of epilepsy is higher with IDH mutation. Anaplastic gliomas are somewhat less likely to manifest with seizures (57%) and are more likely than grade II gliomas to produce mental status, vision, and motor deficits.

Study Type

Observational

Enrollment (Estimated)

100

Contacts and Locations

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

Study Contact

Name: Mohammad Hossam, master
Phone Number: 201005663647
Email: mohammadhossam74@gmail.com

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

N/A

Sampling Method

Non-Probability Sample

Study Population

Each patient will be subjected to:

A complete history including personal history, history of seizures or drug intake.
General clinical examination.
Neurological examination.

Description

Inclusion Criteria:

Patients diagnosed radiologically with low grade glioma

Exclusion Criteria:

patients not fit for surgery

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
Morbidity in low grade glioma patients following surgical management. Time Frame: 2 years	report THE RATE OF POSTOPERATIVE MORBIDITY Among participants using the neurological condition assessment ( kornofisky Scale).	2 years

Collaborators and Investigators

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

Sponsor

Assiut University

Investigators

Study Chair: Ahmed El Gheriani, professor, Professor

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 (Estimated)

August 1, 2024

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

July 1, 2026

Study Registration Dates

First Submitted

May 31, 2024

First Submitted That Met QC Criteria

July 7, 2024

First Posted (Actual)

July 15, 2024

Study Record Updates

Last Update Posted (Actual)