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NCT Number: NCT07491328

Liquid Biopsy in Paraneoplastic Neurological Syndromes

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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Key information

Conditions

Paraneoplastic Neurological Syndromes Neoplasm Metastasis Neoplasms Neoplastic Cells, Circulating Neoplastic Processes Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf

Düsseldorf, 40225, Germany

Location status: Recruiting

Location contact

Johannes Fischer, MD

SUB_INVESTIGATOR

Nico Melzer, MD

CONTACT

[email protected]

+49-(0)211-81-04170

Nico Melzer, MD

PRINCIPAL_INVESTIGATOR

Nikolas H. Stoecklein, MD

SUB_INVESTIGATOR

Saskia Räuber, MD

CONTACT

[email protected]

+49-(0)211-81-04170

Saskia Räuber, MD

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

CTC & ctDNA analysis

Diagnostic Test

Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood

Primary outcomes

  1. CTC detection

    Time frame: Time of enrollment (BL)

    Detection of circulating tumor cells (CTCs) in the peripheral blood

  2. ctDNA detection

    Time frame: Time of enrollment (BL)

    Detection of circulating tumor DNA (ctDNA) in serum

Secondary outcomes

  1. CTC mutation profile

    Time frame: Time of CTC analysis (BL)

    Mutations in oncogenes and tumor suppressor genes

Study contacts

Contact information is provided by the study sponsor or research team.

Nico Melzer, MD

CONTACT

[email protected]

+49-(0)211-81-04170

Saskia Räuber, MD

CONTACT

[email protected]

+49-(0)211-81-04170

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Collaborators

  • Erasmus Medical Center
  • Medical University of Graz
  • University of Regensburg
  • Universität Münster

Registry information

Official study title

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

Acronym: LiB-PNS

Important dates

Study start
2023
Primary completion
2030
Study completion
2030
First posted
Mar 24, 2026
Registry last updated
Mar 24, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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