Whole-Brain Tumor Burden Metrics with Inflammatory and Molecular Markers to Predict Postoperative Neurocognitive Decline in Glioma

March 18, 2025 updated by: Simin Zhang, West China Hospital

Integrating Whole-Brain Tumor Burden Metrics with Inflammatory and Molecular Markers to Predict Postoperative Neurocognitive Decline in Glioma Patients -a Prospective Cohort Study

Although surgical resection improves overall survival in patients with diffuse Low-grade gliomas (DLGG), it can also result in deterioration of neurocognitive function, which are poorly understood and lack effective predictive models. This study aims to develop a model using whole-brain tumor burden metrics, inflammatory and molecular markers for predicting high risk of neurocognitive decline (ND) postoperatively. The study involved 192 patients with left frontal DLGG. MRI data were analyzed to derive whole-brain tumor burden metrics, including tumor radiomics, whole-brain cortical thickness, myelin content, and network characteristics. postoperative inflammatory and molecular markers were collected. Postoperative follow-up neurocognitive function was assessed using the Montreal Cognitive Assessment at 3 months and 1 year. Machine learning models were constructed using Pycaret.

Study Overview

Study Type

Observational

Enrollment (Actual)

192

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

192 glioma patients

Description

Inclusion Criteria:

  1. Histopathologically proven DLGG based on 2021 WHO criteria
  2. Age ≥ 18 years,
  3. Karnofsky Performance Status ≥ 70%,
  4. Tumor involved unilateral left frontal lobe and did not reach the central sulcus.

Exclusion Criteria:

  1. With previous treatment before image acquisition,
  2. Presenting cognitive impairment pre-operatively based on The Montreal Cognitive Assessment (MoCA)
  3. Survival of less than 3 months post-surgery
  4. Lack of compliance with neurocognitive assessments in 3-month and 1-year after 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
neurocognitive function was assessed using the Montreal Cognitive Assessment
Time Frame: 3 month
p neurocognitive function was assessed using the Montreal Cognitive Assessment
3 month

Collaborators and Investigators

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

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 (Actual)

May 1, 2016

Primary Completion (Actual)

September 1, 2024

Study Completion (Actual)

December 1, 2024

Study Registration Dates

First Submitted

March 11, 2025

First Submitted That Met QC Criteria

March 18, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 18, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Glioma

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