NCT06885333

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
192

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2016

Longer than P75 for all trials

Status
completed

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

Study Start

First participant enrolled

May 1, 2016

Completed
8.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2024

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

March 11, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 20, 2025

Completed
Last Updated

March 20, 2025

Status Verified

March 1, 2025

Enrollment Period

8.3 years

First QC Date

March 11, 2025

Last Update Submit

March 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • neurocognitive function was assessed using the Montreal Cognitive Assessment

    p neurocognitive function was assessed using the Montreal Cognitive Assessment

    3 month

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

192 glioma patients

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

GliomaAstrocytoma

Condition Hierarchy (Ancestors)

Neoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
3 Years
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
doctor of department of radiology, Principal Investigator, Clinical Professor

Study Record Dates

First Submitted

March 11, 2025

First Posted

March 20, 2025

Study Start

May 1, 2016

Primary Completion

September 1, 2024

Study Completion

December 1, 2024

Last Updated

March 20, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will share