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

Determining the sensitivity and specificity of circulating tumor cells and cytology in cerebrospinal fluid of patients clinically suspected for leptomeningeal metastases - N12CLM (Identification of Circulating tumor cells in CSF)

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON41394

Enrollment

Registered

2012-05-30

Start date

2012-10-22

Completion date

Unknown

Last updated

2024-05-06

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

Conditions

leptomeningeal metastasis

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

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

Exclusion criteria: Lumbar puncture not clinically / diagnostically indicated

Design outcomes

Primary

Measure	Time frame
Determine the sensitivity and specificity of detection of circulating tumor cells (CTCs) in patients with Epcam expressing tumors compared to cytology in the cerebrospinal fluid of patients, clinically suspected for leptomeningeal metastases	—

Secondary

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

Measure

Time frame

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

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Countries

Netherlands

Outcome results