- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06885333
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
Status
Completed
Conditions
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:
- Histopathologically proven DLGG based on 2021 WHO criteria
- Age ≥ 18 years,
- Karnofsky Performance Status ≥ 70%,
- Tumor involved unilateral left frontal lobe and did not reach the central sulcus.
Exclusion Criteria:
- With previous treatment before image acquisition,
- Presenting cognitive impairment pre-operatively based on The Montreal Cognitive Assessment (MoCA)
- Survival of less than 3 months post-surgery
- 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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2023745
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.
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