Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT03849430 |
| Other study ID # |
S58343 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
December 14, 2015 |
| Est. completion date |
January 1, 2030 |
Study information
| Verified date |
November 2023 |
| Source |
Universitaire Ziekenhuizen KU Leuven |
| Contact |
Steven De Vleeschouwer, MD Phd |
| Phone |
+3216344290 |
| Email |
steven.devleeschouwer[@]uzleuven.be |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational [Patient Registry]
|
Clinical 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. 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.
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.
