Liquid Biopsy in Paraneoplastic Neurological Syndromes

NCT07491328 | Recruiting

• 1 other identifier: 2021-1634
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Paraneoplastic Neurological Syndromes

Keywords

Circulating tumor cells (CTCs); Circulating tumor DNA (ctDNA); Diagnostic leukapheresis (DLA)

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• CTC mutation profile

  Time of CTC analysis (BL)

Study Arms (3)

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

PNS w/o T

PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor

Diagnostic Test: CTC & ctDNA analysis

T w/o PNS

Tumor patients without PNS

Diagnostic Test: CTC & ctDNA analysis

Interventions

CTC & ctDNA analysis DIAGNOSTIC_TEST

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

PNS w/o T; PNS+T; T w/o PNS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• Any mental condition impairing the capacity to provide informed consent.
• Presence of contraindications to DLA.

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• University of Regensburg: collaborator
• Universität Münster: collaborator
• Erasmus Medical Center: collaborator
• Medical University of Graz: collaborator

Study Sites (1)

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

Düsseldorf, 40225, Germany

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Peripheral Blood Mononuclear Cells (PBMCs)

MeSH Terms

Conditions

Neoplastic Cells, Circulating

Interventions

Colonography, Computed Tomographic

Condition Hierarchy (Ancestors)

Neoplasm Metastasis; Neoplastic Processes; Neoplasms; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Tomography, X-Ray Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Radiographic Image Enhancement; Image Enhancement; Photography; Radiography; Tomography, X-Ray; Diagnostic Techniques, Digestive System

Central Study Contacts

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief Consultant Neurologist

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: May 20, 2023
• Primary Completion (Estimated): December 30, 2030
• Study Completion (Estimated): December 30, 2030
• Last Updated: March 24, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)