iquid Biopsy in Neuro-oncology in the St Antonius Hospital
- Conditions
- malignant meningitisneoplasttic meningitis1002921110027655
- Registration Number
- NL-OMON49736
- Lead Sponsor
- eurologie
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 75
Patients who have a clinical indication for a diagnostic lumbar puncture
because of secondary malignancy of the CNS (leptomeningeal metastases and/ or
brain metastases) :
1/ age >18 years
2/ able and willing to give written consent
3/ able and willing to undergo lumbar puncture and venipuncture
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 unable or unwilling to give written consent
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The percentage of CSF / blood samples in which successful mutation analysis can<br /><br>be performed by liquid biopsy<br /><br><br /><br>The number and nature of additional mutations in CSF-ct DNA relative to blood<br /><br>and (if available) solid material of primary tumor<br /><br>Relevant mutations concern mutations involved in therapy resistance and / or<br /><br>new targetable therapies, as described in (dynamic) online databases such as<br /><br>www.pharmgk.org or www.cpct.nl</p><br>
- Secondary Outcome Measures
Name Time Method <p>- comparison between liquid biopsy findings in CSF versus routine parameters in<br /><br>CSF and / or radiological parameters, currently used for the diagnosis of<br /><br>leptomeningeal metastases<br /><br>- correlation between CSF-ct DNA amount and specific mutations with clinical<br /><br>course and survival data<br /><br>- course of tumor mutations over time, when there is a clinical indication for<br /><br>repeated lumbar punctures, and relationship of these mutations to the patient's<br /><br>neurological condition and therapy<br /><br><br /><br>future research goals<br /><br>- detection of specific adhesion molecules or chemokines that play a role in<br /><br>the trophism of solid CNS tumors<br /><br>- detection of new targetable mutations by dd-PCR.</p><br>