Determining the sensitivity and specificity of circulating tumor cells and cytology in cerebrospinal fluid of patients clinically suspected for leptomeningeal metastases

Recruiting

• Conditions: leptomeningeal metastasis; 10006291; 10029211; 10040900

• Registration Number: NL-OMON41394
• Lead Sponsor: Antoni van Leeuwenhoek Ziekenhuis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

1. Patients who are treated for advanced EpCam positive solid tumors (such as breast cancer, lung cancer, gastrointestinal cancer) or melanoma
2. Age >=18 years;
3. Able and willing to give written informed consent;
4. WHO performance status of 0, 1, 2, 3 or 4;
5. Able and willing to undergo lumbar puncture and veni-puncture.

Exclusion Criteria

Lumbar puncture not clinically / diagnostically indicated

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Determine the sensitivity and specificity of detection of circulating tumor<br /><br>cells (CTCs) in patients with Epcam expressing tumors compared to cytology in<br /><br>the cerebrospinal fluid of patients, clinically suspected for leptomeningeal<br /><br>metastases</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- To determine the relationship between the number of CTCs in CSF and the<br /><br>patient*s neurological condition and Karnofsky performance score<br /><br>- To determine the change in the CTC number between two sampling points and<br /><br>correlate this with the patient*s neurological condition and therapy<br /><br>- To determine the relationships between demographics/tumor status and CTCs<br /><br>number in CSF.<br /><br>- To determine the relationship between the CTC cells in the CSF and the CTCs<br /><br>in the peripheral blood<br /><br>- To confirm EPCAM positivity in archived primary tumor tissue and tumorcells<br /><br>in CSF.<br /><br>• To compare the predictive values of two CTC enumeration methods<br /><br>- To investigate CNS distribution of tyrosine kinase inhibitors (e.g.<br /><br>crizotinib,vemurafenib, dabrafenib, erlotinib, gefitinib, afatinib,<br /><br>dacomitinib, trametinib and/or olaparib)<br /><br>- To explore the levels of circulating tumor ctDNA in liquor</p><br>