Liquid Biopsy in Paraneoplastic Neurological Syndromes
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CTC & ctDNA analysis.
- Who it may be relevant to
- Registry conditions: Paraneoplastic Neurological Syndromes. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Germany
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Liquid Biopsy in Paraneoplastic Neurological Syndromes With High- and Intermediate-Risk Antibodies
Overview
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.
Interventions
- Diagnostic test CTC & ctDNA analysis
Analysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood
Primary outcome measures
- CTC detection [Time frame: Time of enrollment (BL)]
- ctDNA detection [Time frame: Time of enrollment (BL)]
Secondary outcome measures (1)
- CTC mutation profile [Time frame: Time of CTC analysis (BL)]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Germany · 1 center
- Department of Neurology, Medical Faculty and University Hospital Düsseldorf, Heinrich Hein — Düsseldorf
Identifiers
NCT: NCT07491328 · 2021-1634