Liquid biopsy to detect tumor cells and tumor DNA in people with paraneoplastic neurological syndromes.
Liquid Biopsy in Paraneoplastic Neurological Syndromes With High- and Intermediate-Risk Antibodies
This project tests whether a large blood collection (diagnostic leukapheresis) plus sensitive lab tests can find circulating tumor cells or tumor DNA in adults with paraneoplastic neurological syndromes, whether or not a tumor is already known.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 1 site (Düsseldorf) |
| Trial ID | NCT07491328 on ClinicalTrials.gov |
What this trial studies
This observational project enrolls adults with paraneoplastic neurological syndromes who have high- or intermediate-risk or GAD65 antibodies, both with and without a detectable tumor, alongside matched patients who have tumors but no PNS. Participants undergo diagnostic leukapheresis and routine blood draws, with samples analyzed by the CELLSEARCH® System for circulating tumor cells and serum tested for cell-free DNA. When circulating tumor cells are identified, detailed molecular genetic analyses will be performed to characterize mutations in oncogenes and tumor suppressor genes. The aim is to determine whether these liquid biopsy methods can reveal hidden tumors or provide molecular information useful for diagnosis and management.
Who should consider this trial
Good fit: Adults (≥18) with paraneoplastic neurological syndromes who have high- or intermediate-risk or GAD65 antibodies, with or without a detectable tumor, and adults with peripheral tumors but no PNS are ideal candidates.
Not a fit: People under 18, those unable to provide informed consent, patients with contraindications to diagnostic leukapheresis, or individuals whose tumors do not release detectable CTCs/ctDNA are unlikely to benefit.
Why it matters
Potential benefit: If successful, this could allow earlier or less invasive detection and molecular characterization of underlying tumors in patients with paraneoplastic neurological syndromes, potentially guiding diagnosis and treatment.
How similar studies have performed: Liquid biopsy methods including CELLSEARCH and ctDNA analysis have detected circulating tumor material in many cancers, but using diagnostic leukapheresis specifically to find tumor signals in PNS is a relatively novel application.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Düsseldorf
- Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf — Düsseldorf, Germany (Recruiting)
Study contacts
- Study coordinator: Nico Melzer, MD
- Email: nico.melzer@med.uni-duesseldorf.de
- Phone: +49-(0)211-81-04170
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.