I. Develop and validate method of MRD detection in body fluids with DNA and/or RNA markers in patients with any central nervous system (CNS) tumor at diagnosis, treatment and follow-up.II. Collect tumor tissue, CSF, PB and urine of all patients with…
ID
Source
Brief title
Condition
- Nervous system neoplasms malignant and unspecified NEC
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Development of techniques for detection of MRD (PCR: RNA-DNA, next
generation sequencing) from any CNS tumor in CSF, PB and urine based on tumor
derived expression profiles for candidate genes or DNA aberrations .
2. Compare efficacy of different methods of MRD detection in different body
fluids in patients with a CNS tumor.
3. Does MRD at diagnosis and its kinetics during therapy relate with any of the
biological subtypes of tumor groups?
4. Does MRD at diagnosis and its kinetics during therapy correlate with
treatment outcome?
The endpoint of this study is to determine the presence and, if present, the
quantification of MRD in body fluids of patients with a CNS tumor at diagnosis,
during treatment and follow-up using different techniques (RQ-PCR, digital PCR
and Next generation sequencing of tumor derived abberations) and correlate this
with staging and outcome.
Secondary outcome
not applicable
Background summary
Sensitive diagnostic biomarkers for tumor dissemination and/or progression are
still lacking in the clinical process of brain tumors. In this study, named
*Biomonitoring of minimal residual disease in neuro-oncology* we investigate
whether highly sensitive techniques for specific biomarkers from the tumor in
cerebrospinal fluid (CSF) and peripheral blood (PB), and other body fluids like
urine, can be developed to:
1. refine the staging of the disease at primary diagnosis (before and after
surgery)
2. improve insight in the kinetics of disappearance of minimal residual disease
(MRD) in relation to therapy
3. detect (an early) relapse during therapy and follow up
Study objective
I. Develop and validate method of MRD detection in body fluids with DNA and/or
RNA markers in patients with any central nervous system (CNS) tumor at
diagnosis, treatment and follow-up.
II. Collect tumor tissue, CSF, PB and urine of all patients with a CNS tumor
for MRD detection after establishing a valid method
Study design
Observational longitudinal cohort study
Study burden and risks
Nature and extent of the burden and risks:
There are no additional risks and the burden of participation is low, since we
will only sample extra blood or CSF, at time points when clinical samples are
being sampled. So no extra blood draws or CSF sampling will be done. This study
will only take extra 2 millilitres (ml) CSF and/or 5 ml PB and a urine sample
at the regular PB and CSF drawings. Primary tumor tissue will be tested by the
pathology department to establish a diagnosis, and when there is material left,
RNA and DNA will be extracted for study of RNA and DNA markers.
Benefit and group relatedness:
There will not be a benefit for patients participating in this study. However,
by participating in this study they help to give insight in the clinical
significance of MRD monitoring in CNS tumors and consequently in the possible
clinical implementation of MRD in risk stratification and treatment allocation.
Meibergdreef 9
Amsterdam 1105 AZ
NL
Meibergdreef 9
Amsterdam 1105 AZ
NL
Listed location countries
Age
Inclusion criteria
- Radiologicaland if possible histological proven diagnosis of any CNS tumor (M0-M4)
- Any age group
- Written informed consent obtained of the patients and/or their parents or legal guardians
Exclusion criteria
see inclusion criteria
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 | NL57841.018.16 |