Conducting research into the role of CSF and blood parameters of patients with CNS lymphoma, focused on improving the diagnostics, identification of biomarkers ('liquid biopsy'), and evaluation of therapy effect.
ID
Source
Brief title
Condition
- Lymphomas non-Hodgkin's B-cell
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Detect specific biomarkers in CSF and/or blood from patients clinically
suspected of primary central nervous system lymphoma. Thereby improving the
diagnosis of CNS lymphoma in a majority of patients and reducing the need for
tissue confirmation through stereotactic biopsy.
Secondary outcome
Possible secondary objectives:
- determine the relationship between the prognosis of CNS lymphoma and specific
biomarkers,
- determine the relationship between specific biomarkers and therapy response.
Background summary
The current role of CSF diagnostics for CNS lymphoma is acknowledged, but
limited to routine cytomorphology and flow cytometry, which can demonstrate
lymphoma only in a minority of patients (<25%). Recent research indicates that
new CSF markers play a role in diagnosing CNS lymphoma, which has the potential
to diagnose CNS lymphoma by CSF investigation, omitting a brain biopsy. Our
meta-analysis showed, however, that none of the available CSF markers are
sufficiently well investigated to rely upon when making clinical decisions.
Whether the evaluation of markers in the blood has additional diagnostic value,
has even been investigated to a lesser extent. Moreover, little is known about
the role of new CSF markers in the follow-up and therapy evaluation of patients
with known CNS lymphoma.
Study objective
Conducting research into the role of CSF and blood parameters of patients with
CNS lymphoma, focused on improving the diagnostics, identification of
biomarkers ('liquid biopsy'), and evaluation of therapy effect.
Study design
A retrospective and prospective cohort study.
Study burden and risks
Regarding the prospective cohort, there is no extra burden due to participation
in this study except for a limited amount of patients for whom the venipuncture
is not clinically indicated. For all patients, lumbar puncture is clinically
indicated. The amount of CSF additionally drawn is approx. 10 ml and the amount
of blood additionally drawn is approx. 67 ml. The risk of participation in this
trial is therefore negligible. Patients also have no personal benefit, as the
investigation of new biomarkers does not immediately influence current standard
clinical care.
Regarding the retrospective cohort, there is no extra burden due to the fact
that only CSF is analysed, which had already been drawn from the patients as
part of clinical care.
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Koekoekslaan 1
Nieuwegein 3430 EM
NL
Listed location countries
Age
Inclusion criteria
1. Suspected or confirmed primary central nervous system lymphoma
2. Age > 18 years
3. Patients who have a clinical indication for a diagnostic lumbar puncture
Exclusion criteria
1) If contra-indications for lumbar puncture are present:
- skin infection
- coagulopathy
- signs or symptoms of increased intracranial pressure
- midline shift or obliteration of basal cisterns on neuro-imaging
2) If a patient is unwilling to give written consent.
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 | NL75887.100.20 |