Long Term Implications of Rare Brain Tumours'
Understanding the Long-term Implications of Treatment of Rare Brain Tumours on Health-related Quality of Life: A European Cross-sectional Study
1 other identifier
observational
267
2 countries
2
Brief Summary
Patients diagnosed with oligodendroglioma with a specific molecular profile represent rare tumour groups (about 10% of adult gliomas) with relatively favourable prognosis (median survival between 8 and 12 years). These patients are often treated with surgery, chemotherapy and/or radiotherapy. However, as patients live for a long period of time, they may also experience long-term toxic side-effects of treatment. The long-term consequences of treatment- and disease-related factors on quality of life and cognitive functioning of these patients are largely unknown. This study aims to investigate quality of life and cognitive functioning in long-term survivors of oligodendroglioma (with IDH mutation and 1p/19q codeletion). This knowledge can support health care professionals prepare patients for any long-term consequences of treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2020
Typical duration for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 29, 2020
CompletedFirst Submitted
Initial submission to the registry
January 7, 2021
CompletedFirst Posted
Study publicly available on registry
January 14, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 28, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2023
CompletedMay 15, 2023
May 1, 2023
2.8 years
January 7, 2021
May 10, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
Health Related Quality of Life - EORTC QLQ-C30
To assess the effects of an Oligodendroglioma diagnosis on health related quality of life, The EORTC QLQ-C30 assesses functioning domains (e.g. physical, emotional, role) and common cancer symptoms (e.g. fatigue, pain, nausea/vomiting, appetite loss - the higher the score of each item, the greater the intensity/frequency of the experience e.g., 'Have you had pain?' (1 = not at all, 2 = a little , 3 = quite a bit, 4 = very much)
through study completion, an average of 1 year
Disease Specific Quality of Life - EORTC QLQ-BN20
To assess the disease specific quality of life of brain tumour patients. The EORTC QLQ-BN20 consists of 20 items that assess future uncertainty, visual disorder, motor dysfunction, and communication deficit. The higher the score of each item, the greater the intensity/frequency of the experience e.g., 'Did you have difficulty speaking?' (1 = not at all, 2 = a little , 3 = quite a bit, 4 = very much)
through study completion, an average of 1 year
Secondary Outcomes (3)
Psychological Distress - Hospital Anxiety and Distress Scale (HADS)
through study completion, an average of 1 year
Fatigue - Multidimensional Fatigue Inventory (MFI)
through study completion, an average of 1 year
Hopkins Verbal Learning Test - Recall
through study completion, an average of 1 year
Study Arms (1)
Oligodendroglioma (Grade II and III) Patients
Patients diagnosed with a WHO Grade II or III Oligodendroglioma
Interventions
Health-related quality of life (HRQOL) is an individual's or a group's perceived physical and mental health over time.
Measured of the distress experienced by patients
Measure of the extreme tiredness resulting from mental or physical exertion or illness
Cognitive functioning refers to multiple mental abilities, including learning, thinking, reasoning, remembering, problem solving, decision making, and attention. This will be measured through self-report and cognitive testing.
Eligibility Criteria
The study population consists of patients with a primary brain tumour (histologically confirmed oligodendroglioma) who are patients at participating centres in the United Kingdom, the Netherlands, Germany, France, and other European countries (discussions with countries/centres are ongoing).
You may qualify if:
- Histologically confirmed oligodendroglioma WHO grade II or III with IDH mutation and 1p/19q co-deletion
- Diagnosis must have been ≥5 years ago
- Patient is ≥18 years of age
- Willing and able to provide written informed consent
You may not qualify if:
- They are expected to be unable to complete consent procedures and/or study outcomes due to legal incompetence or insufficient mastery of the language of the country in which they live as determined by their treating physician.
- They do not provide written informed consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Amsterdam UMC
Amsterdam, North Hollan, 1105 AZ, Netherlands
Leeds Institute of Medical Research
Leeds, West Yorkshire, LS9 7FT, United Kingdom
Related Publications (1)
Boele FW, Frances SM, Darlix A, Ducray F, Cartalat S, Guerdoux E, Tabouret E, Burger MC, Ryden I, Malmstrom A, Vauleon E, Kazda T, Renovanz M, Werner JM, Welsh L, Sanghera P, Dehais C, Desideri I, McBain C, Mehta S, Lord H, Jena R, Foweraker K, Ashkan K, Engelhardt J, Bourg V, Herrlinger U, McLean AL, Hertler C, Haldbo-Classen L, Dahlrot RH, Noel G, Durando X, Hrab I, Razis E, Weller M, Muhic A, Klein M. Health-related quality of life and cognitive functioning in survivors of oligodendroglioma: an international cross-sectional investigation. Neuro Oncol. 2025 Jul 19:noaf172. doi: 10.1093/neuonc/noaf172. Online ahead of print.
PMID: 40692477DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Professor.
Study Record Dates
First Submitted
January 7, 2021
First Posted
January 14, 2021
Study Start
May 29, 2020
Primary Completion
February 28, 2023
Study Completion
February 28, 2023
Last Updated
May 15, 2023
Record last verified: 2023-05
Data Sharing
- IPD Sharing
- Will not share