In this pilot, we aim to improve the detection rate of LM by using the CellSearch technique quantifying circulating tumor cells (CTCs) in cerebrospinal fluid (CSF, i.e. CSFCTs) and compare this with the current standard of care; namely cytological…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Spinal cord and nerve root disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
To compare the detection rate of LM by identifying and quantifying CSFCTs
using the CellSearch technique with the standard of care using CSF cytology
analyses by a pathologist among breast cancer patients with clinical suspicion
of LM.
Secondary outcome
Her2 and ER expression on CTCs in peripheral blood and of the (archived)
primary breast tumor
Molecular profile of CSFCTs, CTCs in peripheral blood and of the (archived)
primary breast tumor
Background summary
Patients with leptomeningeal metastases (LM) have a severely compromised
quality of life (QoL) due to paralysis of cranial and spinal nerves, while
treatment modalities are limited. As a consequence, prognosis is poor with a
median overall survival of only 2.2 - 4.4 months (1).
This inferior outcome is partially explained by a pronounced delay in
diagnosing LM as currently available diagnostic techniques are hampered by a
low sensitivity. Therefore, there is an unmet need for novel diagnostic tests
to increase sensitivity to detect LM
Study objective
In this pilot, we aim to improve the detection rate of LM by using the
CellSearch technique quantifying circulating tumor cells (CTCs) in
cerebrospinal fluid (CSF, i.e. CSFCTs) and compare this with the current
standard of care; namely cytological examination of CSF by the pathologist in
breast cancer patients with clinical suspicion of LM. We hypothesize that the
detection rate of the CellSearch technique is higher compared to cytology.
Study design
In patients with breast cancer suspected of LM in whom the MRI result is
non-conclusive, who have no contra-indications and gave informed consent, a LP
will be performed for regular cytological analysis. Additional liquor (minimal
amount of 4 ml) will be sent to the laboratory to detect and quantify CSFCTs by
the CellSearch technique.
In addition, peripheral blood samples (3x10 ml) will be collected for detect,
quantify and molecular characterize CTCs in blood. Any remnant liquor will be
stored at -80ºC to perform proteomic analysis by mass spectrometry and
molecular analysis of circulating tumor DNA at a later stage.
From all patients clinical data, and outcome will be collected prospectively up
to a max. of 12 months.
Study burden and risks
The burden for patients is limited as there will be no additional invasive
investigations. First of all, only patients who are planned to undergo a lumbar
puncture (LP) for regular care will be asked to participate. Importantly, the
collection of additional liquor during the planned LP will be of no harm for
the patients. Blood sampling for CTC detection in the peripheral circulation is
of very limited harm.
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Groene Hilledijk 301
Rotterdam 3075 EA
NL
Listed location countries
Age
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.
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 | NL53555.078.15 |