The primary study objectives are: (1) to determine the impact of glioma and its treatment on the neurocognitive functioning, health-related quality of life, and mental functioning of LGG patients; and (2) to determine the impact of the disease and…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Neurocognitive functioning in six cognitive domains (attention, executive
functioning, verbal memory, working memory, psychomotor functioning, and
information processing speed); Health-related quality of life.
Secondary outcome
Radiological outcome; Molecular tumor characteristics in long-term survivors;
Radiological determinants of neurocognitive functioning and health-related
quality of life. Develop new, liquid biopsy based, algorithms to separate long
term survivors from short/median term survivors.
Background summary
Our previous research among 65 long-term, 12 year survivors of low-grade glioma
(LGG) shows that patients who did not have radiotherapy had stable radiological
and cognitive status. By contrast, LGG patients who received radiotherapy
showed a progressive decline in attentional functioning, even those who
received fraction doses that are regarded as safe (*2 Gy). These cognitive
deficits are associated with radiological abnormalities. Our results suggest
that the risk of long-term cognitive and radiological compromise that is
associated with radiotherapy should be considered when treatment is planned. We
have identified 46 patients out of the previously mentioned 65 patients who are
still alive at an average of 24 years.
Study objective
The primary study objectives are: (1) to determine the impact of glioma and its
treatment on the neurocognitive functioning, health-related quality of life,
and mental functioning of LGG patients; and (2) to determine the impact of the
disease and its treatment on the quality of life of the informal caregivers of
these patients.
Secondary objectives are to identify clinical parameters and patient
characteristics/host-related factors in long-term survivors, by using liquid
biopsies identify molecular tumor characteristics in long-term survivors, and
to evaluate therapy-related and radiology-related parameters as potential
determinants of neurocognitive functioning and health-related quality of life.
Study design
The study will employ a cross-sectional study of LGG survivors and their
informal caregivers.
Study burden and risks
Considering the median survival of LGG patients of about 7 years, patients
surviving over 24 years are extremely rare. Regarding to patient counseling and
treatment, it is not only of importance to know the determinants of the
clinical status of these patients, but also to discern the biological
determinants of long-term survivorship. Related to the venipuncture the patient
may feel slight pain or a sting when the needle is inserted. The patient may
also feel some throbbing at the site after the blood is drawn. In some cases
the venipuncture may give rise to transient hematoma. Since apart from the
venipuncture the procedure is identical to the 2 previous assessments in which
these patients and informal caregivers participated, they know what to expect.
There are no other risks or benefits for the patients or informal caregivers.
van der Boechorststraat 7
Amsterdam 1081BT
NL
van der Boechorststraat 7
Amsterdam 1081BT
NL
Listed location countries
Age
Inclusion criteria
Histological diagnosis of low-grade glioma (i.e. astrocytomas, oligodendrogliomas, or oligoastrocytomas).
Exclusion criteria
- patient is unable to communicate adequately
- patient has severe limitations in motor functioning
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL56604.029.16 |