PRIMROSE Audit: A multicentre audit of care provided to patients with breast cancer involving the brain in the UK
| ISRCTN | ISRCTN18204314 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN18204314 |
- Submission date
- 13/08/2020
- Registration date
- 19/08/2020
- Last edited
- 07/10/2020
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
Background and study aims
Breast cancer is one of the most common cancers that can spread to the brain. We also know that there are different types of breast cancer and some of these spread more easily to the brain than others. Secondary cancer in the brain is usually deadly and reduces the quality of life in patients.
We wish to understand how breast cancer patients present with disease involving the brain, how they are managed across the UK nor what impact it has on their survival. With this knowledge, we will be able to improve the services and care for these patients.
Who can participate?
Records from patients aged 16 years or older, who suffer from breast cancer with central nervous system involvement.
What does the study involve?
The PRIMROSE audit will involve data that is routinely collected from patients diagnosed with breast cancer involving the brain between January 2020 and December 2021. The collected data will be anonymised before it can be used for research. The data will be collected by clinicians normally involved in the care of these patients.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University of Liverpool
When is the study starting and how long is it expected to run for?
January 2020 to July 2022
Who is funding the study?
Daiichi-Sankyo (Japan)
Who is the main contact?
Professor Carlo Palmieri, c.palmieri@liv.ac.uk
Contact information
Public
Department of Molecular and Clinical Cancer Medicine
Institute of Translational Medicine
Sherrington Building, Ashton Street
University of Liverpool
Liverpool
L69 3GE
United Kingdom
 ORCID ID |
0000-0001-9496-2718 |
|---|---|
| Phone | +44 (0)151 706 3616 |
| c.palmieri@liv.ac.uk |
Study information
| Study design | Prospective observational multi centre audit |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Other |
| Participant information sheet | No participant information sheet available |
| Scientific title | PRIMROSE Audit: A Prospective Multi-Centre Project to Assess the Presentation, Management, and Outcomes of Patients with CNS Disease Secondary to Breast Cancer |
| Study acronym | PRIMROSE |
| Study hypothesis | To capture the local and regional variation in the presentation, diagnosis and management of patients with CNS disease secondary to breast cancer in the UK |
| Ethics approval(s) | The PRIMROSE audit does not require research ethics committee (REC) review as it is an audit, and not a research project. This has been confirmed using the Health Research Authority (HRA) decision tools and as advised on the tools, we have sought further guidance from an HRA Approvals Specialist. Documents confirming the outcome of these are available on request. Local audit approvals will need to be obtained, with a supervising named consultant, if the unit lead is a trainee. |
| Condition | Central Nervous System disease secondary to breast cancer |
| Intervention | Patients' records will be reviewed to collect routine care data on demographic information, clinicopathological features and treatment of primary breast cancer, information relating to disease recurrence, prior cancer treatment for non-CNS metastatic disease (if applicable), surgical and radiotherapy treatment of CNS disease (if applicable), current anti-cancer treatment and concomitant medication, cancer-related outcomes |
| Intervention type | Other |
| Primary outcome measure | Overall survival from initial diagnosis of CNS involvement secondary breast cancer measured using patient records at a single time point. |
| Secondary outcome measures | Measured at a single time point: 1. Number of cases of metastatic breast cancer involving the CNS presenting in UK centres per year measured using patient records 2. Current practice in UK centres regarding the diagnosis and management of CNS disease secondary to breast cancer in relation to national and international guidelines: 2.1. Prior cancer treatment for non-CNS metastatic disease 2.2. Surgical and radiotherapy treatment of CNS disease 2.3. Current anti-cancer treatment and concomitant medications 3. Outcomes of patients treated for CNS involvement secondary to breast cancer in UK centres: 3.1. Time to progression from surgery, radiotherapy or systemic therapy, defined as time from commencement of treatment for CNS disease to disease progression and site of progression 3.2. Overall survival measured as the time from diagnosis of recurrent disease until death of any cause 3.3. Cause of death: Progressive CNS disease versus progressive disease at other sites |
| Overall study start date | 01/01/2020 |
| Overall study end date | 31/12/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | As an audit/project, no formal sample size is set based on audit/project hypothesis. A target for the audit is to obtain 300 patients and given the poor prognosis of the target population it is a reasonable target that 100 events will be observed. |
| Participant inclusion criteria | 1. ≥16 years of age 2. Histologically and/or cytologically confirmed breast cancer with CNS involvement, as defined as having one or more of the following: 2.1. Metastases to the brain parenchyma 2.2. Metastases to the leptomeninges 2.3. Paraneoplastic Neurological Disorders |
| Participant exclusion criteria | Does not meet inclusion criteria |
| Recruitment start date | 01/08/2020 |
| Recruitment end date | 31/07/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Edgbaston
Birmingham
B15 2WB
United Kingdom
Southampton
Hampshire
Southampton
SO16 6YD
United Kingdom
Manchester
M20 4BX
United Kingdom
Brownlow Hill
Liverpool
L69 3BX
United Kingdom
1345 Govan Rd
Glasgow
G51 4TF
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Sponsor information
University/education
1st Floor
Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3GL
England
United Kingdom
| Phone | +44 (0)151 794 2405 |
|---|---|
| primrose@liverpool.ac.uk | |
| Website | http://www.liv.ac.uk/ |
"ROR" |
https://ror.org/04xs57h96 |
Funders
Funder type
Industry
Private sector organisation / For-profit companies (industry)
- Alternative name(s)
- Daiichi Sankyo Company, Limited, Daiichi Sankyo Co., Ltd.
- Location
- Japan
Results and Publications
| Intention to publish date | 01/03/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | The results of the audit from different participating sites will be analysed together and published in the name of the audit as soon as possible, on behalf of all collaborators, maintaining participant confidentiality at all times. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date. |
Editorial Notes
07/10/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/07/2021 to 31/07/2022.
2. The overall trial end date has been changed from 31/07/2022 to 31/12/2022.
3. The intention to publish date has been changed from 31/12/2022 to 01/03/2023.
20/08/2020: The trial participating centre 'St. Mary's Hospital' was added.
19/08/2020: Trial’s existence confirmed by Daiichi-Sankyo
