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| Name | Class |
|---|---|
| University of Regensburg | OTHER |
| Universität Münster | OTHER |
| Erasmus Medical Center | OTHER |
| Medical University of Graz |
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The main objective of the study is to assess whether circulating tumor cells (CTCs) can be detected in the peripheral blood of patients with paraneoplastic neurological syndromes (PNS) by diagnostic leukapheresis (DLA) combined with the CELLSEARCH® System during clinical routine workup. If CTCs can be identified, a detailed molecular genetic analysis will be performed to characterize mutations in oncogenes and tumor suppressor genes. In addition, the study aims to analyze cell-free DNA (cfDNA) in serum of patients.
Individuals with PNS and high- or intermediate-risk or GAD65-antibodies with a detectable tumor (PNS+T), PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor (PNS w/o T), and matched tumor patients without PNS (T w/o PNS) will be included in the study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PNS+T | Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies with a detectable tumor |
| |
| PNS w/o T | PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor |
| |
| T w/o PNS | Tumor patients without PNS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CTC & ctDNA analysis | Diagnostic Test | Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood |
|
| Measure | Description | Time Frame |
|---|---|---|
| CTC detection | Detection of circulating tumor cells (CTCs) in the peripheral blood | Time of enrollment (BL) |
| ctDNA detection | Detection of circulating tumor DNA (ctDNA) in serum | Time of enrollment (BL) |
| Measure | Description | Time Frame |
|---|---|---|
| CTC mutation profile | Mutations in oncogenes and tumor suppressor genes | Time of CTC analysis (BL) |
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Inclusion Criteria:
Exclusion Criteria:
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The study population will include patients with paraneoplastic neurological syndromes (PNS) and matched tumor patients without PNS.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nico Melzer, MD | Contact | +49-(0)211-81-04170 | nico.melzer@med.uni-duesseldorf.de | |
| Saskia Räuber, MD | Contact | +49-(0)211-81-04170 | SaskiaJanina.Raeuber@med.uni-duesseldorf.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf | Recruiting | Düsseldorf | 40225 | Germany |
All pseudonymized IPD that underlie the results in a publication.
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| ID | Term |
|---|---|
| D009360 | Neoplastic Cells, Circulating |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D023881 | Colonography, Computed Tomographic |
| ID | Term |
|---|---|
| D014057 | Tomography, X-Ray Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
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| OTHER |
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Peripheral Blood Mononuclear Cells (PBMCs)
| D013568 |
| Pathological Conditions, Signs and Symptoms |
| D003933 | Diagnosis |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D003938 | Diagnostic Techniques, Digestive System |