INDEPENDENT STATISTICIAN REQUIRED

We are looking for an independent statistician to join the Trial Steering Committee for two distinct studies led by Professor Carlo Palmieri.

A brief description of the studies are presented below.

The aim of the steering committee is to provide overall independent supervision of the trial including safeguarding the interests of the PRIMROSE Tissue Study participants, assessing the safety and efficacy of the trial. Collectively, the members have the scientific, medical and clinical trial management experience to conduct and evaluate the trial and have joint oversight of the design, conduct and analysis of the study.  The Committee should endeavour to ensure that the trial is conducted at all times to comply with Good Clinical Practice (GCP).

The frequency of scheduled TSC meetings will be decided at the initial meeting but it is likely to be one to three times a year. The meetings can be attended remotely (I imagine after the pandemic passes too).

If you are interested in supporting the study by becoming the TSC statistician, or would like more information - please contact Dr. Richard Jackson ([log in to unmask]<mailto:[log in to unmask]>) or myself ([log in to unmask]<mailto:[log in to unmask]>), enclosing your research CV and outlining your relevant experience of such committees, if any.

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PRIMROSE Tissue Study: A collection of tissue and CSF from patients with CNS disease secondary to breast cancer.

Brief Description: This is a prospective non-interventional multicentre research study. Patients with histological confirmed locally advanced or metastatic breast cancer who meet the entry criteria will be provided with details of the study and consented. The study enables the collection of biological material collected during the course of routine care.

There are no interventions and blinding or randomisation is not required. Patients will continue to receive standard care and no patient-reported outcomes or additional assessments are required to be collected.

Primary objective
This study seeks to collect tissue (FFPE blocks of primary breast cancer, non-CNS metastasis - if available and/or brain metastasis - if available) and CSF samples (which are routinely collected as part of clinical care) to support future research with the following objectives,
i) To investigate molecular/genetic concordance between primary and metastatic cancer sites
ii) Investigate potential molecular or genetic markers for diagnosis and/or therapy within CSF and other collected tissue.

Specific objectives the study intends to meet are as follows:
? To investigate the concordance between the primary and brain metastasis for ER, PgR and HER2
? The prevalence and concordance of the expression of the androgen receptor within brain metastasis as compared to primary disease.
? To investigate the genomic landscape of CNS disease secondary to breast cancer.


PRIMROSE CSF: A single arm prospective cohort sample collection study of the genomic landscape of central nervous system disease secondary to breast cancer utilising cell free DNA derived from cerebrospinal fluid.

Study Description: This is a prospective cohort sample collection multicentre study. Patients with histological confirmed locally advanced or CNS disease secondary to breast cancer metastasis cancer who meet the entry criteria will be provided with details of the study and consented before registration. Patients entering the study will have CSF collected via a lumbar puncture (with atraumatic needles unless discussed with the chief investigator) or by aspiration from their Ommaya reservoir which is already in situ. This procedure will be in addition to standard care treatments.

Primary objectives
? To determine the feasibility of recruiting patients to undergo lumbar puncture or aspiration of Ommaya Reservoir to enable the collection of cerebrospinal fluid.
? To determine the molecular aberrations, present within CSF cell-free DNA (cfDNA).

Secondary objectives
To determine
? The proportion of cases with an actionable mutation based on CSF cfDNA findings using the TARGET (Tumour Alterations Relevant for Genomics-Driven Therapy) database.
? The concordance between CSF cfDNA and brain metastases for detected mutations (applicable where brain metastasis has been resected).
? The concordance between plasma cfDNA and brain metastases for detected mutations (applicable where brain metastasis has been resected).
? The concordance between plasma cfDNA and CSF cfDNA for detected mutations.
? The complications post-lumbar puncture or aspiration of CSF from an Ommaya reservoir (This will not apply to patients undergoing lumbar puncture at the time of neurosurgical procedure).
Exploratory objectives
? To compare the genomic landscape between paired CSF paired samples (i.e. where collected at different time points)


Thank you and kind regards

Elaine Howarth
Senior Statistician, Liverpool Clinical Trials Centre,
The University of Liverpool, 1st floor Clock C, Waterhouse Building, 3 Brownlow Street, Liverpool. L69 3GL

Email: [log in to unmask]<mailto:[log in to unmask]>


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