Liquid Biopsy in Paraneoplastic Neurological Syndromes (LiB-PNS)

Liquid Biopsy in Paraneoplastic Neurological Syndromes With High- and Intermediate-Risk Antibodies

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.

Study Overview

• Status: Recruiting
• Conditions: Paraneoplastic Neurological Syndromes
• Intervention / Treatment: Diagnostic test: CTC & ctDNA analysis

• Study Type: Observational
• Enrollment (Estimated): 60

Contacts and Locations

• Study Contact: Name: Nico Melzer, MD; Phone Number: +49-(0)211-81-04170; Email: nico.melzer@med.uni-duesseldorf.de
• Study Contact Backup: Name: Saskia Räuber, MD; Phone Number: +49-(0)211-81-04170; Email: SaskiaJanina.Raeuber@med.uni-duesseldorf.de

Study Locations

• Germany
  • Düsseldorf, Germany, 40225
    • Recruiting
    • Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
    • Contact: Nico Melzer, MD; Phone Number: +49-(0)211-81-04170; Email: nico.melzer@med.uni-duesseldorf.de
    • Contact: Saskia Räuber, MD; Phone Number: +49-(0)211-81-04170; Email: SaskiaJanina.Raeuber@med.uni-duesseldorf.de
    • Principal Investigator: Nico Melzer, MD
    • Sub-Investigator: Saskia Räuber, MD
    • Sub-Investigator: Nikolas H. Stoecklein, MD
    • Sub-Investigator: Johannes Fischer, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population will include patients with paraneoplastic neurological syndromes (PNS) and matched tumor patients without PNS.

Description

Inclusion Criteria:

• Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies or
• Patients with peripheral tumors without PNS

Exclusion Criteria:

• Age below 18 years at the time of inclusion.
• Any mental condition impairing the capacity to provide informed consent.
• Presence of contraindications to DLA.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
PNS+T; Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies with a detectable tumor	Diagnostic test: CTC & ctDNA analysis; Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood
PNS w/o T; PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor	Diagnostic test: CTC & ctDNA analysis; Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood
T w/o PNS; Tumor patients without PNS	Diagnostic test: CTC & ctDNA analysis; Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
CTC mutation profile	Mutations in oncogenes and tumor suppressor genes	Time of CTC analysis (BL)

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Collaborators: Medical University of Graz; Erasmus Medical Center; University of Regensburg; Universität Münster

Study record dates

Study Major Dates

• Study Start (Actual): May 20, 2023
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030

Study Registration Dates

• First Submitted: March 18, 2026
• First Submitted That Met QC Criteria: March 18, 2026
• First Posted (Actual): March 24, 2026

Study Record Updates

• Last Update Posted (Actual): March 24, 2026
• Last Update Submitted That Met QC Criteria: March 18, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Keywords: Circulating tumor cells (CTCs); Circulating tumor DNA (ctDNA); Diagnostic leukapheresis (DLA)
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplastic Processes; Neoplasm Metastasis; Pathological Conditions, Signs and Symptoms; Neoplastic Cells, Circulating; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Digestive System; Diagnostic Imaging; Radiography; Image Interpretation, Computer-Assisted; Radiographic Image Enhancement; Image Enhancement; Photography; Tomography, X-Ray; Tomography, X-Ray Computed; Colonography, Computed Tomographic
• Other Study ID Numbers: 2021-1634

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All pseudonymized IPD that underlie the results in a publication.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No