RecruitingNCT07503704

A Prospective Study of the Genomic Landscape of Central Nervous System Disease Secondary to Breast Cancer Utilising Cell-free DNA Derived From Cerebrospinal Fluid (CSF)

PRIMROSE - A Prospective Study of the Genomic Landscape of Central Nervous System Disease Secondary to Breast Cancer Utilising Cell-free DNA Derived From Cerebrospinal Fluid (CSF)


Sponsor

Royal College of Surgeons, Ireland

Enrollment

69 participants

Start Date

Oct 1, 2024

Study Type

OBSERVATIONAL

Conditions

Summary

The PRIMROSE CSF Study aims to study cerebrospinal fluid (CSF) in patients with breast cancer that has spread to the brain (brain metastasis) or the lining surrounding the brain (leptomeningeal disease). Research into breast cancer that has spread to the brain or the lining of the brain is limited due to difficulty in obtaining brain tissue containing cancer cells. Such tissue is typically only available when tumours are removed, which does not occur in all patients. Evidence indicates an increasing number of patients with breast cancer are developing disease that spreads to the brain or the lining of the brain as treatments improve. The PRIMROSE CSF Study aims to improve understanding of breast cancers that spread to the brain or brain lining by collecting and analysing the fluid that circulates around the brain and comparing these samples with other cancer and blood samples. Cancer cells that have spread to the brain or its lining shed genetic material into the surrounding fluid. Collection of this fluid enables purification of genetic material released by breast cancer cells. This approach allows examination of the genetic profile of breast cancer cells affecting the brain or its lining without the need for surgery. Differences between the original cancer and metastatic disease in the brain can then be analysed. This research will support improved understanding of why certain breast cancers spread to the brain and contribute to the development of new treatments for breast cancer that has spread to the brain or the lining of the brain.


Eligibility

Min Age: 18 YearsMax Age: 99 Years

Plain Language Summary

Simplified for easier understanding

The PRIMROSE CSF Study collects cerebrospinal fluid (the fluid surrounding the brain and spinal cord) from breast cancer patients whose cancer has spread to the brain (brain metastases) or the lining of the brain (leptomeningeal disease), in order to analyze the genetic makeup of those cancer cells without requiring surgery. By comparing genetic material found in spinal fluid, blood, and tumor samples, researchers hope to better understand why some breast cancers spread to the brain and to help develop new treatments. Adults over 18 of any gender with newly diagnosed or progressive breast cancer brain metastasis or leptomeningeal disease who can provide informed consent are eligible; the only exclusion is if a lumbar puncture (spinal tap) or Ommaya reservoir aspiration is considered unsafe. Participation primarily involves providing fluid and blood samples alongside standard cancer care. This summary was prepared as patient-facing educational content using AI assistance.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Beaumont RCSI Cancer Centre

Dublin, Ireland

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NCT07503704


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