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Diagnosing Brain Metastases in cerebrospinal fluid

Diagnosis of brain metastases with liquid biopsies by nanopore-based methylation signatures - NOMAD-study - Nanopore-based Methylation Analysis for Diagnosing Brain Metastases

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON58373
Enrollment
62
Registered
2025-05-16
Start date
2026-06-05
Completion date
Unknown
Last updated
2026-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Brain metastases Cancer that has spread to the brain

Interventions

Patients will undergo lumbar puncture to collect CSF.&nbsp

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 64 Years

Inclusion criteria

Inclusion criteria: patients ³ 18 years old with cerebral metastases with available histopathological diagnosis from the brain who have undergone lumbar puncture < 6 weeks pre-operative OR 2-6 weeks postoperative (samples only used for testing technical feasibility)patients who are ³ 18 years old and are suspected of having brain metastases and requiring surgery (either biopsy or resection) ORpatients who are ³ 18 years old with available histopathological diagnosis from the brain who are discussed in our local tumor board if patients have already undergone any systemic treatment, this is not a contra-indication for inclusion. 

Exclusion criteria

Exclusion criteria: A potential participant who meets any of the following criteria will be excluded from participation in this study:The unavailability of a histopathological diagnosis of cerebral tissueThe presence of leptomeningeal metastases demonstrated by cytology or circulating tumor cellsInability to Provide Informed Consent: Patients unable to understand or sign the informed consent form (e.g., due to cognitive impairment, language barrier).Patients who have any contra-indication for a lumbar puncture according to the standard of clinical care guidelines Patients using anti-thrombotics (either clopidogrel or anticoagulants such as DOACs) for whom there is no reason to discontinue them before surgery.Patients with increased intracranial pressure (e.g., suspected brain edema or mass lesion).Spinal deformities or conditions (e.g., severe scoliosis, kyphosis, or previous spinal surgery at the lumbar region) that may complicate the procedure.Severe Thrombocytopenia: platelet count < 50,000/µL, INR > 1.5, or prolonged aPTTLocal Infection - presence of infection at or near the puncture site (e.g., cellulitis or abscess).

Design outcomes

Primary

MeasureTime frame
This is a diagnostic proof of concept study wherein we assess whether a test (methylation in CSF) is as good as an existing test (methylation and histomolecular classification on tissue samples). Our determinant is methylation in CSF and our outcome measure, or golden standard, is methylation and histomolecular classification on tissue samples. We will assess the level of agreement between the tests, meaning that we aim to evaluate whether the CSF methylation classifier can distinguish between different types of brain metastases as accurately as histopathological tissue analysis does.

Secondary

MeasureTime frame
n.v.t. 

Countries

Netherlands

Contacts

Public ContactE van Kessel

Universitair Medisch Centrum Utrecht

polineuro-oncologie@umcutrecht.nl+31 88 75 568 77

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP) · Data processed: Jul 23, 2026