Detection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients

Detection of circulating tumour cells in cerebrospinal fluid (CSFCTs) to diagnose leptomeningeal metastases (LM) among breast cancer patients - CTCs in liquor

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON50559

Enrollment

Registered

2015-11-09

Start date

2016-01-20

Completion date

Unknown

Last updated

2025-03-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

metastases in central nervous system of breast cancer

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Countries

Netherlands

Outcome results