NCT07416838

Brief Summary

The aim of this study is to introduce appropriate assessment instruments and to define patients with gliomas according to cognitive functioning and quality of life. The study will evaluate cognitive functioning as a prognostic factor for survival in patients with glial tumors and will support optimization of treatment strategies to improve patients' quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

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

September 21, 2018

Completed
6.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

February 6, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

February 18, 2026

Completed
Last Updated

February 18, 2026

Status Verified

February 1, 2026

Enrollment Period

6.3 years

First QC Date

February 6, 2026

Last Update Submit

February 13, 2026

Conditions

Keywords

Glial Tumors

Outcome Measures

Primary Outcomes (1)

  • Change in Quality of Life Score (EORTC QLQ-C30 and QLQ-BN20)

    Quality of life will be assessed using the European Organisation for Research and Treatment of Cancer questionnaires EORTC QLQ-C30 and the brain cancer module EORTC QLQ-BN20. Scores range from 0 to 100 points. The outcome will be reported as mean change in questionnaire score (points) from baseline to each follow-up assessment.

    Baseline (before treatment); 6 weeks; 3 months; 6 months; 12 months

Secondary Outcomes (1)

  • Change in Cognitive Function Test Performance (Neuropsychological Test Battery)

    Baseline (before treatment); 6 weeks; 3 months; 6 months; 12 months

Study Arms (1)

Glioma Patients

OTHER

Patients with glial tumors assessed for quality of life and cognitive functioning as prognostic factors.

Other: Cognitive Functioning and Quality of Life Assessment

Interventions

Assessment of cognitive functioning and quality of life in patients with glial tumors to evaluate their prognostic value and impact on survival outcomes.

Glioma Patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult participants (≥18 years)
  • Patients with histologically confirmed glial tumour
  • Ability to understand the study procedures and provide written informed consent
  • Ability to complete quality of life questionnaires and cognitive testing

You may not qualify if:

  • Age \<18 years
  • Inability to provide informed consent
  • Severe cognitive impairment or clinical condition preventing completion of questionnaires and cognitive testing
  • Insufficient language proficiency to complete the questionnaires and neuropsychological testing

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Oncology Ljubljana

Ljubljana, 1000, Slovenia

Location

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2026

First Posted

February 18, 2026

Study Start

September 21, 2018

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

February 18, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations