Glioma of BrainGlioma2015NCT03849430
Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients
An observational study of Glioma of Brain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
Trial summary
Gliomas are the most common primary intracranial tumors, representing at least 75% of all primary malignant brain tumors. Histopathologically, gliomas are classified into different subgroups including astrocytomas (60-70%), oligodendrogliomas (10-30%), ependymomas (<10%) and mixed gliomas (i.e. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glioma of Brain
- How many people
- 750 participants
- Where
- 1 siteBelgium
- Study dates
- 14 Dec 2015to 1 Jan 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The GLIOMA-2015 study will include adult patients that will be diagnosed and/or operated and/or treated and followed-up for a low- or high grade glioma in UZ Leuven.
Who may be able to join
- age ≥ 18 years
- patients diagnosed and treated for a high- or low grade glioma
- treatment in UZ Leuven
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients and Setting Up a Large-scale, Prospective Database for Glioma Patients Treated in UZ Leuven
Gliomas are the most common primary intracranial tumors, representing at least 75% of all primary malignant brain tumors. Histopathologically, gliomas are classified into different subgroups including astrocytomas (60-70%), oligodendrogliomas (10-30%), ependymomas (<10%) and mixed gliomas (i.e. oligoastrocytomas) depending on the cell type from which they originate. The World Health Organization currently classifies gliomas based on histopathological analysis in which the presence (or absence) and the degree of specific histopathological features determines the grade of malignancy. Grade I (pilocytic astrocytoma) and grade II (diffuse astrocytoma, oligodendroglioma, mixed oligoastrocytoma, and pleomorphic xanthoastrocytoma) are termed low-grade gliomas (LGGs), whereas grade III (anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma) and grade IV (glioblastoma) represent high-grade gliomas (HGGs).
Given the incurable nature of gliomas, the maintenance or improvement of the patient's quality of life are extremely important. The benefits of multimodal treatment strategies, in terms of prolonged survival or delay of progression, have to be carefully balanced against the side effects of the treatment, which may adversely influence patient's functioning and well-being during his/her remaining life span.
Read more
Measuring a brain tumor patients functioning and well-being goes far beyond assessing (progression-free) survival or tumor response to treatment on imaging. A more integrated way to measure patients functioning and well-being is the assessment of a patient's health-related quality of life (HRQOL). HRQOL is defined as a personal self-assessed ability to function in the physical, psychological, emotional, and social domains of day-to-day life.
The main goal of this study is to perform a large-scale, prospective and long-term analysis of the HRQOL in patients diagnosed with glioma.
Read the detailed description
Aims of the study
The main goal of this study is to perform a large-scale, prospective and long-term analysis of the HRQOL in patients diagnosed with glioma and to set up a database which contains general patient characteristics, tumor information, treatment strategy and follow-up data of each included patient. This large-scale database will allow the investigator to investigate several relevant research questions in a well-documented group of glioma patients.
Methodology
HRQOL is a multidimensional concept covering physical, psychological and social domains as well as symptoms induced by the disease and the treatment. Currently there is no single gold standard tool to measure HRQOL, and several valid measures of HRQOL in brain tumor patients are available. In this study the investigator will use the EQ-5D questionnaire to report patient's HRQOL. The EQ-5D is widely used and has been validated in many different patient populations. It has been designed so that patients can describe the extent to which they have a problem in each of the five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression The timing of the HRQOL questionnaires will depend on whether a patient will be diagnosed with either a LGG or a HGG. Moreover, as the current treatment strategies for LGG patients and for relapsed HGG patients are highly variable, the investigator scheduled the HRQOL measurements not in function of the treatment, but rather in function of the classical, standard-of-care patient follow-up (either 3 or 6 monthly).
Missing data
When there are missing data for some patients, the question arises as to whether patients with missing data differ from those who returned completed forms. As a consequence, missing data presents problems in the analysis and the interpretation of the results. Hence, the amount of missing data should be minimized. A regular check on missing data will be performed by the CTA. In case the HRQOL form was not completed by the included patient, the patient will be contacted by phone or e-mail and he/she will be asked to provide an answer to the different questions of the HRQOL questionnaire in order to avoid missing data. In case the patient is unable to complete the HRQOL questionnaire, the CTA will report the reason for non-completion in the database.
- Conditions
- Glioma of Brain
- Keywords
- Low grade glioma, High grade glioma, HRQOL
- Medical subject headings
- Glioma
What is being measured
The primary outcome is the main question the study is designed to answer.
Change over time of quality of life from diagnosis until end of active treatment
Quality of life is assessed using the EQ-5D-5L (EuroQol 5 Dimensions 5 Level scale), which has 2 components. The description component measures health status in terms of 5 dimensions; mobility (ability to walk), self-care (ability to wash or dress by oneself), usual activities (performance in work, study, housework, family or leisure activities), pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondents self-rate their level of severity for each dimension. Each level of each dimension corresponds to a 1-digit number. All together a 5-digit number describes the patient's health state (3,125 (55) different health states are possible). In the evaluation component, the respondents evaluate their overall health status by valuing health-related quality of life from 0 (corresponding to the worst health you can imagine) to 100 (corresponding to the best health you can imagine).
Measured: Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first
Survival
Date of decease will be reported in a prospective database
Measured: At time of decease or up to 10 year
Secondary outcomes (1)
Treatment strategy
All treatment details will be reported in a prospective database
Measured: From date of first diagnoses until date of decease or up to 10 year, whichever came first
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start14 Dec 2015
- Primary completion1 Jan 2030 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Glioma of BrainStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 750 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Dr. Steven De Vleeschouwer, Universitaire Ziekenhuizen KU Leuven
- Investigators
- Steven De Vleeschouwer, MD Phd, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849430
- Sponsor's protocol ID
- S58343
- Acronym
- Glioma2015
- Status last verified
- Mar 2025
- First submitted
- 19 Feb 2019
- Last updated
- 1 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Longitudinal Analysis of the Health-related Quality of Life in Glioma Patients and Setting Up a Large-scale, Prospective Database for Glioma Patients Treated in UZ Leuven
- ClinicalTrials.gov ID
- NCT03849430
- Acronym / sponsor ID
- Glioma2015 / S58343
- Conditions
- Glioma of Brain
- Keywords
- Low grade glioma, High grade glioma, HRQOL
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 750 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- 14 Dec 2015 (actual)
- Primary completion
- 1 Jan 2030 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 21 Feb 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Gliomas are the most common primary intracranial tumors, representing at least 75% of all primary malignant brain tumors. Histopathologically, gliomas are classified into different subgroups including astrocytomas (60-70%), oligodendrogliomas (10-30%), ependymomas (<10%) and mixed gliomas (i.e. oligoastrocytomas) depending on the cell type from which they originate. The World Health Organization currently classifies gliomas based on histopathological analysis in which the presence (or absence) and the degree of specific histopathological features determines the grade of malignancy. Grade I (pilocytic astrocytoma) and grade II (diffuse astrocytoma, oligodendroglioma, mixed oligoastrocytoma, and pleomorphic xanthoastrocytoma) are termed low-grade gliomas (LGGs), whereas grade III (anaplastic astrocytoma, anaplastic oligodendroglioma or anaplastic oligoastrocytoma) and grade IV (glioblastoma) represent high-grade gliomas (HGGs).
Given the incurable nature of gliomas, the maintenance or improvement of the patient's quality of life are extremely important. The benefits of multimodal treatment strategies, in terms of prolonged survival or delay of progression, have to be carefully balanced against the side effects of the treatment, which may adversely influence patient's functioning and well-being during his/her remaining life span.
Measuring a brain tumor patients functioning and well-being goes far beyond assessing (progression-free) survival or tumor response to treatment on imaging. A more integrated way to measure patients functioning and well-being is the assessment of a patient's health-related quality of life (HRQOL). HRQOL is defined as a personal self-assessed ability to function in the physical, psychological, emotional, and social domains of day-to-day life.
The main goal of this study is to perform a large-scale, prospective and long-term analysis of the HRQOL in patients diagnosed with glioma.
Detailed description
Aims of the study
The main goal of this study is to perform a large-scale, prospective and long-term analysis of the HRQOL in patients diagnosed with glioma and to set up a database which contains general patient characteristics, tumor information, treatment strategy and follow-up data of each included patient. This large-scale database will allow the investigator to investigate several relevant research questions in a well-documented group of glioma patients.
Methodology
HRQOL is a multidimensional concept covering physical, psychological and social domains as well as symptoms induced by the disease and the treatment. Currently there is no single gold standard tool to measure HRQOL, and several valid measures of HRQOL in brain tumor patients are available. In this study the investigator will use the EQ-5D questionnaire to report patient's HRQOL. The EQ-5D is widely used and has been validated in many different patient populations. It has been designed so that patients can describe the extent to which they have a problem in each of the five dimensions of health: mobility, self-care, usual activities, pain/discomfort and anxiety/depression The timing of the HRQOL questionnaires will depend on whether a patient will be diagnosed with either a LGG or a HGG. Moreover, as the current treatment strategies for LGG patients and for relapsed HGG patients are highly variable, the investigator scheduled the HRQOL measurements not in function of the treatment, but rather in function of the classical, standard-of-care patient follow-up (either 3 or 6 monthly).
Missing data
When there are missing data for some patients, the question arises as to whether patients with missing data differ from those who returned completed forms. As a consequence, missing data presents problems in the analysis and the interpretation of the results. Hence, the amount of missing data should be minimized. A regular check on missing data will be performed by the CTA. In case the HRQOL form was not completed by the included patient, the patient will be contacted by phone or e-mail and he/she will be asked to provide an answer to the different questions of the HRQOL questionnaire in order to avoid missing data. In case the patient is unable to complete the HRQOL questionnaire, the CTA will report the reason for non-completion in the database.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The GLIOMA-2015 study will include adult patients that will be diagnosed and/or operated and/or treated and followed-up for a low- or high grade glioma in UZ Leuven.
Key inclusion criteria (3 listed)
- age ≥ 18 years
- patients diagnosed and treated for a high- or low grade glioma
- treatment in UZ Leuven
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change over time of quality of life from diagnosis until end of active treatment
Time frame: Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first
Quality of life is assessed using the EQ-5D-5L (EuroQol 5 Dimensions 5 Level scale), which has 2 components. The description component measures health status in terms of 5 dimensions; mobility (ability to walk), self-care (ability to wash or dress by oneself), usual activities (performance in work, study, housework, family or leisure activities), pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The respondents self-rate their level of severity for each dimension. Each level of each dimension corresponds to a 1-digit number. All together a 5-digit number describes the patient's health state (3,125 (55) different health states are possible). In the evaluation component, the respondents evaluate their overall health status by valuing health-related quality of life from 0 (corresponding to the worst health you can imagine) to 100 (corresponding to the best health you can imagine).
Survival
Time frame: At time of decease or up to 10 year
Date of decease will be reported in a prospective database
1 secondary outcome
Treatment strategy
Time frame: From date of first diagnoses until date of decease or up to 10 year, whichever came first
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Steven De Vleeschouwer, MD Phd principal investigator
UZ Leuven
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Glioma of Brain, run by Universitaire Ziekenhuizen KU Leuven at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 1 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Steven De Vleeschouwer, MD Phd (+3216344290, steven.devleeschouwer@uzleuven.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change over time of quality of life from diagnosis until end of active treatment (time frame: Every 3 months, from diagnosis until date of decease or up to 10 year, whichever came first). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Apr 2025.