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RecruitingNCT07491328LiB-PNSUpdated Mar 24, 2026

Liquid Biopsy in Paraneoplastic Neurological Syndromes

An observational study in Paraneoplastic Neurological Syndromes, sponsored by Heinrich-Heine University, Duesseldorf. Recruiting at 1 site in Germany. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-03-24.

Sponsored by Heinrich-Heine University, Duesseldorf · Observational

From the registry’s dates

  • Started May 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Paraneoplastic Neurological Syndromes

Keywords

  • Circulating tumor cells (CTCs)
  • Circulating tumor DNA (ctDNA)
  • Diagnostic leukapheresis (DLA)
03

In context

Neoplastic Cells, Circulating

227 studies on the registry are indexed under Neoplastic Cells, Circulating; 54 are open to participants now.

This study's planned enrollment of 60 is below the median of 120 across 121 observational studies indexed under Neoplastic Cells, Circulating.

Browse Neoplastic Cells, Circulating studies →

Lead sponsor

Heinrich-Heine University, Duesseldorf is the lead sponsor of 180 studies on the registry; 54 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Age below 18 years at the time of inclusion.
  • Any mental condition impairing the capacity to provide .
  • Presence of to DLA.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

  • Diagnostic testCTC & ctDNA analysis

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

06

What researchers measure

Primary outcomes

  1. CTC detection

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

    Time frame: Time of enrollment (BL)

  2. ctDNA detection

    Detection of circulating tumor DNA (ctDNA) in serum

    Time frame: Time of enrollment (BL)

Secondary outcomes

  1. CTC mutation profile

    Mutations in oncogenes and tumor suppressor genes

    Time frame: Time of CTC analysis (BL)

07

Study locations

1 of 1 sites recruiting
  • Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
    Düsseldorf, 40225, Germany
    Recruiting
08

References and documents

Individual participant data

Plan to share: Yes — All pseudonymized IPD that underlie the results in a publication.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started May 2023 (actual). Primary completion is estimated for Dec 2030, 91 months after the start.

Of 59 observational studies under Neoplastic Cells, Circulating, half reached primary completion within 93 months of starting (the median), counting those still running; a quarter within 38. This study's planned 91 months is close to that.

How these figures are worked out, and which studies are left out of them.

Registered
Mar 18, 2026
First posted
Mar 24, 2026
StartActual
May 20, 2023
Primary completionEst.
Dec 30, 2030
CompletionEst.
Dec 30, 2030
Last update
Mar 24, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Mar 24, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07491328
Collaborators
University of Regensburg, Universität Münster, Erasmus Medical Center, Medical University of Graz
Responsible party
PD Dr. Nico Melzer (Chief Consultant Neurologist, Heinrich-Heine University, Duesseldorf) — Principal investigator
First posted
Mar 24, 2026
Start date
May 20, 2023
Primary completion
Dec 30, 2030 (estimated)
Completion
Dec 30, 2030 (estimated)
Last update
Mar 24, 2026

Study contacts

Nico Melzer, MD
Contact
nico.melzer@med.uni-duesseldorf.de
+49-(0)211-81-04170
Saskia Räuber, MD
Contact
SaskiaJanina.Raeuber@med.uni-duesseldorf.de
+49-(0)211-81-04170

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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