Evaluation of clinical pathways and patient outcomes for breast magnetic resonance imaging (MRI) in preoperative assessment and staging of breast cancer: Establishing when MRI improves patient outcomes and when it does not. A multicentre prospective observational trial (BCT 2001 Breast MRI Evaluation)
Breast Cancer Trials (BCT)Dataset description
THIS DATASET IS NOT YET AVAILABLE FOR SHARING. Dataset of 406 women involved in an observational study to see if a breast Magnetic Resonance Imaging (MRI) of women recently diagnosed with breast cancer impacts on their treatment planning and cancer outcomes. The primary outcome is the clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients whose suggested treatment changes from before they have MRI to after they have MRI as assessed from patient medical records. PROMS explore the participant experience of undergoing MRI, collected at baseline (pre-MRI), post-surgery and at 12 months after registration. Data collected includes preference for surgery type, Ontario Decisional Conflic Scale, EQ-5D-5L, measure of impact of MRI on patient confidence, Decision Regret Scale. Cancer Australia demographic data has been collected including: Year of birth, Postcode of usual residence, Indigenous Status, CALD status (Country of Birth, Main language other than English used as the principle means of communication).Subjects
Cancer diagnosis |Identifiers
Source Study
Trial acronym
Not available
Trial ID
ACTRN12620000282987
Purpose
Not available
Phase
Not Applicable
Funding
Government body,Medical Research Future Fund
Scientific enquiries
Prof Christobel Saunders
Brief Summary
This study aims to find out if having a breast MRI after being diagnosed with breast cancer might change plans for treating the breast cancer and how this might affect patient outcomes. Who is it for? This study may be suitable if you are 18 years or older, have been recently diagnosed with breast cancer and your medical team has suggested that having a breast MRI will help plan your treatment. Trial Details Participants will not need any extra or different procedures or treatments over and abov .... Read more
Key Inclusion Criteria
For inclusion in the study, participants must fulfil all the following criteria: 1) Provide written, informed consent to participate in the study. 2) Female >= 18 years with newly diagnosed early or locally advanced breast cancer for local staging and: a. With ultrasound/mammography, clinical examination results that are discrepant with respect to surgical and other treatment planning; AND/OR b. < 70 years with invasive lobular cancer; AND/OR c. < 50 years; AND/OR d. With reported extreme breast .... Read more
Key Exclusion Criteria
Any one of the following is regarded as a criterion for exclusion from the study: 1) Distant metastatic disease beyond the breast and locoregional ipsilateral lymph nodes. 2) Locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement. 3) Previous cancer on the same side. 4) Classical lobular carcinoma in situ (LCIS) (pleomorphic LCIS is acceptable). 5) Other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that w .... Read more
Can healthy volunteers participate?
No
Population
Sample Size 406
Min. age 18 Years
Max. age No limit
Sex Females
Condition category Breast Cancer
Condition code Cancer , Public Health
Intervention
Intervention code Diagnosis / Prognosis
Participants diagnosed with early breast cancer whose medical team suggests that they have an MRI will be followed to determine if having an MRI changes their treatment plan and how this affects cancer outcomes. This research does not involve any interventional treatment and will not be altering patient treatments or outcomes. This an observational study in which the researchers take note of information collected during standard care and treatment and from the questionnaires participants are ask .... Read more
Comparison
Control group Uncontrolled
No control group.
Outcomes
Outcome: The clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients whose suggested treatment changes from before they have MRI to after they have MRI as assessed from patient medical records.Timepoint: Treatment decision made immediately after having MRI.
Outcome: The clinical utility of MRI in women with newly diagnosed breast cancer on treatment outcomes measured by the proportion of patients who require further breast surgery due to positive margins or suspected residual invasive or in situ disease as assessed from patient medical records..Timepoint: At any time after primary surgery up to 2 years after registration..
Will individual participant data (IPD) for this trial be available?
yes
What data in particular will be shared?
Anonymised Individual Patient Data (IPD) collected during the trial.
When will data be available?
Data will be made available for request after publication of the main/final study results; no end date. Note that there may be additional circumstances preventing BCT from sharing requested data as outlined in the BCT Data Sharing Guidelines .
Available to whom?
Researchers who submit a research proposal and BCT Data Request Application, which is assessed by BCT to have appropriate scientific value. Refer to the BCT Data Sharing Guidelines
Available for what types of analyses?
To achieve the aims in the approved proposal.