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Completed

NCT Number: NCT06885333

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

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.

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Key information

Conditions

Glioma Astrocytoma Glioma : Oligodendroglioma or Astrocytoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. neurocognitive function was assessed using the Montreal Cognitive Assessment

    Time frame: 3 month

    p neurocognitive function was assessed using the Montreal Cognitive Assessment

Sponsors and collaborators

Lead sponsor

West China Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2024
Study completion
2024
First posted
Mar 20, 2025
Registry last updated
Mar 20, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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