Paraneoplastic Neurological SyndromesLiB-PNSNCT07491328
Liquid Biopsy in Paraneoplastic Neurological Syndromes
An observational study of Paraneoplastic Neurological Syndromes, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Paraneoplastic Neurological Syndromes
- What is being tested?
- CTC & ctDNA analysis
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- 20 May 2023to 30 Dec 2030
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study population will include patients with paraneoplastic neurological syndromes (PNS) and matched tumor patients without PNS.
Who may be able to join
- Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies or
- Patients with peripheral tumors without PNS
Who cannot join
- Age below 18 years at the time of inclusion.
- Any mental condition impairing the capacity to provide informed consent.
- Presence of contraindications to DLA.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Germany1 site, 1 recruiting
- Recruiting
Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf
Düsseldorf, 40225
Nico Melzer, MD, +49-(0)211-81-04170, nico.melzer@med.uni-duesseldorf.de
Saskia Räuber, MD, +49-(0)211-81-04170, SaskiaJanina.Raeuber@med.uni-duesseldorf.de
About this study
Official title: 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.
- Conditions
- Paraneoplastic Neurological Syndromes
- Being tested
- CTC & ctDNA analysis
- Keywords
- Circulating tumor cells (CTCs), Circulating tumor DNA (ctDNA), Diagnostic leukapheresis (DLA)
- Medical subject headings
- Neoplastic Cells, Circulating
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CTC & ctDNA analysisDiagnostic test
Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood
| Study group | Role | What they receive |
|---|---|---|
| PNS+T | Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies with a detectable tumor Receives: Diagnostic Test: CTC & ctDNA analysis | |
| PNS w/o T | PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor Receives: Diagnostic Test: CTC & ctDNA analysis | |
| T w/o PNS | Tumor patients without PNS Receives: Diagnostic Test: CTC & ctDNA analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
CTC detection
Detection of circulating tumor cells (CTCs) in the peripheral blood
Measured: Time of enrollment (BL)
ctDNA detection
Detection of circulating tumor DNA (ctDNA) in serum
Measured: Time of enrollment (BL)
Secondary outcomes (1)
CTC mutation profile
Mutations in oncogenes and tumor suppressor genes
Measured: Time of CTC analysis (BL)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2026
- Study start20 May 2023
- Primary completion30 Dec 2030 (estimated)
- Study completion30 Dec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Paraneoplastic Neurological SyndromesStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Collaborators
- University of Regensburg, Universität Münster, Erasmus Medical Center, Medical University of Graz
- Responsible party
- Principal investigator, PD Dr. Nico Melzer, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07491328
- Sponsor's protocol ID
- 2021-1634
- Acronym
- LiB-PNS
- Status last verified
- Mar 2026
- First submitted
- 18 Mar 2026
- Last updated
- 24 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All pseudonymized IPD that underlie the results in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Liquid Biopsy in Paraneoplastic Neurological Syndromes With High- and Intermediate-Risk Antibodies
- ClinicalTrials.gov ID
- NCT07491328
- Acronym / sponsor ID
- LiB-PNS / 2021-1634
- Conditions
- Paraneoplastic Neurological Syndromes
- Keywords
- Circulating tumor cells (CTCs), Circulating tumor DNA (ctDNA), Diagnostic leukapheresis (DLA)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Collaborators
- University of Regensburg, Universität Münster, Erasmus Medical Center, Medical University of Graz
- Study start
- 20 May 2023 (actual)
- Primary completion
- 30 Dec 2030 (estimated)
- Study completion
- 30 Dec 2030 (estimated)
- First posted
- 24 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| PNS+T | – | Diagnostic Test: CTC & ctDNA analysisPatients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies with a detectable tumor |
| PNS w/o T | – | Diagnostic Test: CTC & ctDNA analysisPNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor |
| T w/o PNS | – | Diagnostic Test: CTC & ctDNA analysisTumor patients without PNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study population will include patients with paraneoplastic neurological syndromes (PNS) and matched tumor patients without PNS.
Key inclusion criteria (2 listed)
- Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies or
- Patients with peripheral tumors without PNS
Key exclusion criteria (3 listed)
- Age below 18 years at the time of inclusion.
- Any mental condition impairing the capacity to provide informed consent.
- Presence of contraindications to DLA.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CTC & ctDNA analysisAnalysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood | Diagnostic test | PNS w/o T, PNS+T, T w/o PNS |
Primary outcome
CTC detection
Time frame: Time of enrollment (BL)
Detection of circulating tumor cells (CTCs) in the peripheral blood
ctDNA detection
Time frame: Time of enrollment (BL)
Detection of circulating tumor DNA (ctDNA) in serum
1 secondary outcome
CTC mutation profile
Time frame: Time of CTC analysis (BL)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2026.
- Individual participant dataSharing planned: Yes. All pseudonymized IPD that underlie the results in a publication.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Paraneoplastic Neurological Syndromes, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 24 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nico Melzer, MD (+49-(0)211-81-04170, nico.melzer@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CTC detection (time frame: Time of enrollment (BL)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2026.