NCT07503704 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)
| NCT ID | NCT07503704 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Royal College of Surgeons, Ireland |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 69 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2028-10-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 69 participants in total. It began in 2024-10-01 with a primary completion date of 2028-10-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: 1. Male or female. 2. \>18 years of age 3. Any ER, PgR or HER2 status 4. Newly diagnosed with Breast Cancer Brain Metastasis (BCBM) OR Progressive BCBM following either local or systemic treatment OR Leptomeningeal disease 5. Informed Consent Exclusion Criteria: 1. Where the investigator considers it unsafe to undertake a lumbar puncture or perform an aspiration from the Ommaya reservoir. 2. Unable to comply with study procedures or give informed consent. 3. Where the investigator considers it not in the best interest of the patient to participate.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07503704 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 99 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07503704 currently recruiting?
Yes, NCT07503704 is actively recruiting participants. Contact the research team at breastcancerbank@rcsi.ie for enrollment information.
Where is the NCT07503704 trial being conducted?
This trial is being conducted at Dublin, Ireland.
Who is sponsoring the NCT07503704 clinical trial?
NCT07503704 is sponsored by Royal College of Surgeons, Ireland. The trial plans to enroll 69 participants.
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