PRIMROSE Tissue: Collection and Analysis of samples in breast cancer
Research type
Research Study
Full title
PRIMROSE TISSUE STUDY: A COLLECTION AND ANALYSIS OF TISSUE AND CSF SAMPLES FROM PATIENTS WITH CNS DISEASE SECONDARY TO BREAST CANCER
IRAS ID
287714
Contact name
Carlo Palmieri
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
No Reference Number, Daiichi Sankyo GmBH
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
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.
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.
REC name
North West - Greater Manchester East Research Ethics Committee
REC reference
20/NW/0451
Date of REC Opinion
21 Jan 2021
REC opinion
Further Information Favourable Opinion