Detection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients
Completed
- Conditions
- metastases in central nervous system of breast cancer1000629110041543
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
Study population:
- Breast cancer patients with clinical suspicion of LM who are planned to
undergo a LP to confirm/exclude the diagnosis LM
- Signed informed consent, Control Group:
- Patients with a hematologic malignancy, who are planned to undergo a LP for
CSF analysis to confirm or to exclude the diagnosis LM, will be included as
negative controls.
- Signed informed consent.
Exclusion Criteria
Study Population:
- Contra-indication for LP (on the discretion of the treating neurologist),
Control Group:
- Contra-indication for LP (on the discretion of the treating neurologist)
- A medical history of a solid malignancy.
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare the detection rate of LM by identifying and quantifying CSFCTs<br /><br>using the CellSearch technique with the standard of care using CSF cytology<br /><br>analyses by a pathologist among breast cancer patients with clinical suspicion<br /><br>of LM.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Her2 and ER expression on CTCs in peripheral blood and of the (archived)<br /><br>primary breast tumor<br /><br><br /><br>Molecular profile of CSFCTs, CTCs in peripheral blood and of the (archived)<br /><br>primary breast tumor</p><br>