Breast Cancer Cancer Malignant neoplasm of breast
Conditions
Interventions
Data Collection: Most of the data should be collected retrospectively sourced from medical records and patient medical notes (Data will be collected on Demographic Information, Clinico-pathological in
Sponsors
University of Liverpool
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female 2. >=16 years of age 3. Any ER, PgR or HER2 status 4. Newly diagnosed with BCBM OR Progressive BCBM following either local or systemic treatment OR Leptomeningeal disease 5. Informed Consent
Exclusion criteria
Exclusion criteria: 1. Unable to comply with study procedures or give informed consent 2. Where the investigator considers it unsafe to undertake a lumbar puncture or perform an aspiration from the Ommaya reservoir 3. Where the investigator considers it not in the best interest of the patient to participate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Feasibility outcomes: 1. RECRUITMENT 1.1. Recruitment rate: defined as the total number of patients randomised per month measured using populated REDCAP eCRFs 1.2. Site opening: defined as the time take to open the target number of sites measured using LCTC Portal 2. STUDY PROTOCOL 2.1. Patient adherence to protocol: to determine whether the patient and/or caregivers adhere to the conditions of the protocol, measured via the number of minor or major protocol deviations measured using ... 2.2. Review of the practicality of delivering interventions measured using Monitoring Reports and discussions held at TMG 3. SAMPLE SIZE INFORMATION 3.1. The estimation of quantities required for an accurate sample size calculation, such as the standard deviation of the outcome measure 4. DATA COLLECTION 4.1. The proportion of expected CRFs returned and the rate of missing key data items 5. PATIENT ACCEPTABILITY 5.1. Estimate drop-out rates: We are not anticipating any patient drop-outs 5.2. Participation rates measured as a proportion of those patients recruited | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Actionable mutations found in CSF cfDNA that match a specific gene database, namely TARGET (Tumour Alterations Relevant to Genomics Driven Therapy) gene database measured using genome analysis after all samples have been collected 2. Complications post lumbar puncture or aspiration of CSF from an Ommaya reservoir measured using a patient questionnaire and a clinician questionnaire post-procedure (eCRF will be used to record the date, the ease of the procedure complications and the need for intravenous fluid and/or analgesia) | — |
Countries
England, Scotland, United Kingdom
Outcome results
None listed