PRIMROSE CSF - Cerebrospinal Fluid Collection in Breast Cancer
Research type
Research Study
Full title
PRIMROSE CSF Study: A prospective study of the genomic landscape of central nervous system disease secondary to breast cancer utilising cell-free DNA derived from cerebrospinal fluid (CSF).
IRAS ID
286155
Contact name
Neil French
Contact email
Sponsor organisation
University of Liverpool
Clinicaltrials.gov Identifier
AR2019.09, North West Cancer Research Grant letter "Re: Project Proposal AR2019.09"; No Reference Number, Daiichi Sankyo GmBH; No Reference Number, Make Seconds Count
Duration of Study in the UK
3 years, 0 months, 1 days
Research summary
PRIMROSE Cerebrospinal Fluid (CSF) Study aims to collect and investigate CSF samples and related data from patients with central nervous system disease secondary to breast cancer.
Screening and Registration
Patients will be informed of the study and consented to participate in PRIMROSE CSF. Following consent, patients will undergo an additional procedure to collect CSF and blood samples.
In addition to CSF and blood collection, diagnostic/routine available FFPE tissue of primary breast cancer, non-cranial metastatic tissue or cranial metastatic tissue (if available) will be collected.First CSF sample collection visit
CSF and blood samples will be collected at the 1st CSF collection visit for all patients (this will be booked in following consent).2nd CSF sample collection visit
Some patients will return for a 2nd CSF collection visit, at which a further CSF and blood sample will be collected. The 2nd sample will only be requested at disease progression, or if the patient is doing well 3 months following the 1st CSF procedure as it is event driven.Disease Progression or Event Driven Follow up (e.g. neurosurgery or relapse)
Collection of data at disease progression, treatment changes and death.The study can be carried out by trained clinical staff members, at sites with the appropriate and relevant facilities and none of the studies involve experimental treatment or placebo treatment.
REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
20/WM/0296
Date of REC Opinion
11 Jan 2021
REC opinion
Further Information Favourable Opinion