Liquid Biopsy in Paraneoplastic Neurological Syndromes (LiB-PNS)

Heinrich-Heine University, Duesseldorf

Status: Enrolling

Conditions: Paraneoplastic Neurological Syndromes

Treatments: Diagnostic Test: CTC & ctDNA analysis

Study type: Observational

Funder types: Other

Identifiers

NCT07491328

2021-1634

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

60 participants in 3 patient groups

PNS+T

Description:

Patients with paraneoplastic neurological syndromes (PNS) and high- or intermediate-risk or GAD65-antibodies with a detectable tumor

Treatment:

Diagnostic Test: CTC & ctDNA analysis

PNS w/o T

Description:

PNS patients with high- or intermediate-risk or GAD65-antibodies without detectable tumor

Treatment:

Diagnostic Test: CTC & ctDNA analysis

T w/o PNS

Description:

Tumor patients without PNS

Treatment:

Diagnostic Test: CTC & ctDNA analysis