PRIMROSE Tissue: collection and analysis of samples in breast cancer
| ISRCTN | ISRCTN13938848 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN13938848 |
| IRAS number | 287714 |
| Secondary identifying numbers | CPMS 47662, IRAS 287714 |
- Submission date
- 12/02/2021
- Registration date
- 21/05/2021
- Last edited
- 21/05/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Breast cancer is the most common type of cancer in the UK.
PRIMROSE Tissue Study aims to collect and investigate archived tissue, excess CSF samples and related data (all collected as part of standard care) from patients with central nervous system disease secondary to breast cancer. This study does not involve additional procedures or interventions outside of standard care.
Who can participate?
Patients aged 16 years or above, with breast cancer
What does the study involve?
Patients will be informed of the study and consented to participate in PRIMROSE Tissue. Following consent, arrangements will be made to request available archived FFPE tissue blocks of primary breast cancer tissue, non-cranial metastatic tissue or cranial metastatic tissue if available.
CSF samples will be collected only if the patient has been scheduled to undergo a CSF collection procedure as part of their standard care. In this case, an excess 10ml of CSF will be collected for the PRIMROSE Tissue study. Prior to CSF collection, 10ml blood will be collected for the study (which would not otherwise be collected).
The study can be carried out by trained clinical staff members, at sites with the appropriate and relevant facilities and this study does not involve experimental treatment or placebo treatment.
What are the possible benefits and risks of participating?
None
Where is the study run from?
University of Liverpool (UK)
When is the study starting and how long is it expected to run for?
January 2021 to June 2025
Who is funding the study?
1. Daiichi-Sankyo (Japan)
2. Liverpool Experimental Cancer Medicine Centre (UK)
Who is the main contact?
Contact information
Scientific
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 | Observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Diagnostic |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet. |
| Scientific title | Primrose tissue study: a collection and analysis of tissue and CSF samples from patients with CNS disease secondary to breast cancer |
| Study objectives | PRIMROSE Tissue Study aims to collect and investigate archived tissue, excess CSF samples and related data (all collected as part of standard care) from patients with central nervous system disease secondary to breast cancer. |
| Ethics approval(s) | Approved 21/01/2021, North West – Greater Manchester (GM) East (3rd Floor, Barlow House, 4 Minshull Street, M1 3DZ, UK; +44 (0)207 104 8009; gmeast.rec@hra.nhs.uk), ref: 20/NW/0451 |
| Health condition(s) or problem(s) studied | Breast Cancer |
| Intervention | Data and Tissue Collection After Enrolment After written consent is given and after patient has been enrolled in the study the data should be entered into the database (from retrospective records sourced from medical records and patient medical notes). The research team at site should request available FFPE tissue blocks and send to the University of Liverpool GCP Laboratory according to the Laboratory Manual. CSF Extraction Visit This visit will only occur if the patient is undergoing a CSF extraction procedure as per standard care. The following procedures will occur at this visit: •Blood sample collection (1 x 10ml EDTA blood tube) – this should be collected immediately before the CSF extraction procedure •Excess CSF sample extraction (1 x 10ml CSF tube and 1 x 3ml - 5ml CSF tube) – this should be carried out via Lumbar Puncture or Ommaya Reservoir aspiration or at standard care neurosurgery as per standard procedure (atraumatic needles should be used unless discussed with PI & CI). The CSF samples for the PRIMROSE Tissue study will be excess samples taken at the time of the standard care CSF extraction procedure. Scan/Imaging Visit This visit will only occur if the patient is booked in for a routine can as part of their standard care pathway. The Scan/Imaging Visit eCRF should be completed. Disease Progression Visit If patient comes in for a routine visit and there are no changes in disease or treatment, then there is no requirement to update eCRF. In the event of patient disease progression, treatment changes or in the event of death, data and tissue will be collected as relevant. Participant Discontinuation/Withdrawal In consenting to the trial, participants agree to all trial activities including sample collection and data collection. Every effort should be made to facilitate the completion of these for every recruited participant. If it is not possible to complete these activities (or it is deemed inappropriate) the reasons why should be documented. Patients may be withdrawn from the study for any of the following reasons: -Patient (or their designated legal representative, where applicable) withdraws consent. -Contraindications to collection procedures. -Death -Clinician-led - Any change in the patient’s condition which results in a contraindication to collection procedures or causes the patient to fall under the exclusion criteria. - Any change in the patient’s condition that justifies discontinuation of involvement in the clinician’s opinion. Data to be collected at the time of discontinuation includes date of discontinuation and reason for discontinuation. If a patient wishes to withdraw, the value of existing samples should be explained, and permission sought to continue retaining and using these. Generally, samples will be retained unless it is specifically requested for them not to be. Upon withdrawal, the LCTC and TMG should be informed in via eCRF and no further samples or data should be collected. Permission will be sought to use all samples collected thus far in the case of withdrawal. However, patients have the right to request that any samples which have not yet already been used in research to be disposed of. If a patient explicitly states that this is their wish, then this will be recorded onto eCRF. In some cases, it will be impossible to destroy the samples without affecting other samples as they will have been irreversibly linked to others (such as in cases of tissue microarrays being produced or plasma samples being pooled). In these cases, the sample itself will not be destroyed; however, information linking the sample to any patient identifiers will be destroyed, deleted or censored as appropriate to eliminate the link and make the sample unidentifiable. End of Study The end of the study is defined to be the date on which data for all participants is frozen and data entry privileges are withdrawn from the study database. The study may be closed prematurely by the Trial Steering Committee. |
| Intervention type | Other |
| Primary outcome measure | Clinical staff will be collecting information onto eCRFs (REDCap) at registration (1st or 2nd Visit), CSF Extraction Visit, Imaging/ Scan Visit, Disease Progression Visit: 1. Disease history and characteristics 2. Prior cancer therapy (top line) 3. Current anti-cancer treatment and concomitant medications Progression Details |
| Secondary outcome measures | There are no secondary outcome measures |
| Overall study start date | 21/01/2021 |
| Completion date | 01/06/2025 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 16 Years |
| Sex | Both |
| Target number of participants | Planned Sample Size: 300; UK Sample Size: 300 |
| Key inclusion criteria | 1. 16 years of age or above 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 3. FFPE of biopsied or resected primary breast cancer, non-CNS metastasis and/ or brain metastasis is available or will be available. 4. Informed consent |
| Key exclusion criteria | 1.Unable to comply with study procedures or give informed consent |
| Date of first enrolment | 01/06/2021 |
| Date of final enrolment | 01/06/2023 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
Study participating centres
Liverpool
L9 7LJ
United Kingdom
Bearsden
G61 1QH
United Kingdom
Herries Road
Sheffield
S5 7AU
United Kingdom
Tremona Road
Southampton
SO16 6YD
United Kingdom
Prescot Street
Liverpool
L7 8XP
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
Sponsor information
University/education
1st Floor
Block C
Waterhouse Building
3 Brownlow Street
Liverpool
L69 3BX
England
United Kingdom
| Phone | +44 (0)151 794 2405 |
|---|---|
| sponsor@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
No information available
Results and Publications
| Intention to publish date | 01/06/2026 |
|---|---|
| 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 | Planned publication in a high-impact peer-reviewed journal. |
| IPD sharing plan | The current data sharing plans for this study are unknown and will be available at a later date |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version v2.0 | 20/10/2020 | 21/05/2021 | No | No |
| HRA research summary | 28/06/2023 | No | No |
Additional files
- ISRCTN13938848_PROTOCOL_v2.0_20Oct2020.pdf
- Uploaded 21/05/2021
Editorial Notes
21/05/2021: Uploaded protocol Version 2.0, 20 October 2020 (not peer reviewed).
12/02/2021: Trial’s existence confirmed by National Institute for Health Research (NIHR).
