Liquid Biopsy in Paraneoplastic Neurological Syndromes
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHeinrich-Heine University, Duesseldorf
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies or
Patients with peripheral tumors without PNS
Disqualifiers
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 population
The study population will include patients with paraneoplastic neurological syndromes (PNS) and matched tumor patients without PNS.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CTC & ctDNA analysis
Diagnostic testAnalysis of circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA) in the peripheral blood
Treatment groups
60 Participants
are divided into 3 treatment groupsGroup A: PNS+T1 intervention
Group B: PNS w/o T1 intervention
Group C: T w/o PNS1 intervention
Trial outcomes
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Heinrich-Heine University, Duesseldorf
Lead sponsor
University of Regensburg
Collaborator
Universität Münster
Collaborator
Erasmus Medical Center
Collaborator
Medical University of Graz
Collaborator
Source ClinicalTrials.gov