Stratified Medicine Programme 2

SMP1 proved both feasible within the NHS and acceptable to patients, with >99% of patients approached agreeing to take part in this research. Stratified Medicine Programme 2 represents an advancement to SMP1 and for the first time within the UK, links national pre-screening to a national trial in oncology. Through its Stratified Medicine Programme 2, Cancer Research UK is taking ambitious and significant steps towards making targeted therapies available to eligible cancer patients in the UK

SMP2 is a collaborative programme, launched in 2014 and focussed on lung cancer, between Cancer Research UK, the Experimental Cancer Medicine Centres Network, NHS, University of Birmingham Cancer Research Clinical Trials Unit (CRCTU), Illumina, Astra Zeneca and Pfizer, and provides a national pre-screening service to the National Lung Matrix Trial.

The clinical network has expanded from 8 to across all 18 ECMCs, and through a hub and spoke model is recruiting patients from >45 NHS sites in order to offer equity of access to as many patients as possible. Clinical sites (SMP2 Clinical Hubs (ECMCs) or SMP2 Feeder Sites) identify and consent eligible patients to allow for their excess diagnostic biopsy tissue to be sent for genetic testing using Next Generation Sequencing, at one of three central NHS molecular diagnostic laboratories (Technology Hubs).

SMP2 has been designed to harness local clinical pathways and processes in order to provide eligible patients with an additional treatment option. Genetic testing through SMP2 is designed to take place in parallel with the patient receiving first line treatment. The NGS results are returned electronically to the local clinical team and patients’ treating oncologist, in a clinically relevant timeframe. Eligible patients may then be consented to participate in the National Lung Matrix Trial.

SMP2 Sites

Clinical Hub (CH):

The SMP2 CHs are based upon the ECMC network of 18 NHS sites. These hospitals screen and consent patients using either a local consent form or the specific CRUK SMP2 form. They coordinate the sending of high quality samples and associated clinical data to their paired Technology Hub and to CRUK (data only). They are also opened as full Matrix Trial sites in order for patients to be treated locally. CHs receive money directly from CRUK in the form of a grant released by an electronic grants management system called eGMS. The value stated on the Grant Award Letter will be calculated based on their target number of samples to be sent annually which will have previously been agreed with CRUK.

Belfast	Belfast City Hospital
Birmingham	The Queen Elizabeth Hospital
Cambridge	Addenbrooke’s Hospital
Cardiff	Velindre Cancer Centre
Edinburgh	Western General Hospital
Glasgow	Beatson West of Scotland Cancer Centre
Leeds	St. James’s Hospital
Leicester	Leicester Royal Infirmary
London, Chelsea	The Royal Marsden Hospital
London, Hammersmith	Charing Cross Hospital
London, Smithfield	St Bartholomew’s Hospital
London, Southwark	University College Hospital
London	Guy’s Hospital
Manchester	The Christie Hospital
Newcastle	Freeman Hospital
Oxford	Churchill Hospital
Sheffield	Weston Park Hospital
Southampton	Southampton General Hospital
Sutton	The Royal Marsden Hospital

SMP2 Feeder Site ‘Type A’:

Responsibilities will be broadly the same as those that exist for a CHs. Sites will be paired with a CH and TH. Sites are responsible for screening and consenting patients and arranging for samples meeting the SMP2 eligibility criteria, to be sent to their linked TH.  Sites will typically not have the ability to use the electronic database that the CH has locally for SMP2. Sites will be expected to provide clinical data on a pro-forma to their paired CH, who will in turn upload this data and send XMLs to the designated TH on behalf of the feeder site. Feeder sites will not receive an individual grant for the SMP2 work; the sample target set for the central Clinical Hub will be increased accordingly (following target discussion with the feeder site) and the money sent to the Clinical Hub for appropriate distribution to feeder sites. Contracts may need to be put in place to allow this monetary distribution as well as data transfer. Feeder Site ‘Type A’ will also open as Matrix Trial sites, enabling patients to be treated locally.

SMP2 Feeder Site ‘Type B’:

As for Site Type A except that site B will not open as a full Matrix Trial sites. Patients will be referred into the paired CH for treatment. ‘Type B’ sites may have the opportunity to open as a Matrix feeder site.

Molecular profiling and characterisation of patients’ tumour are performed at one of three centralised laboratories, referred to as Technology Hubs (THs). The THs are either ISO 15189 or CPA accredited NHS Molecular Genetics Laboratories located at Birmingham (West Midlands Regional Genetics Service), Cardiff (All Wales Medical Genetics Service) and The Royal Marsden Hospital, London (The Centre for Molecular Pathology) and are paired evenly across the CHs. Upon receipt of leftover diagnostic lung biopsy tissue and matched blood sample, DNA is extracted and analysed by next generation sequencing (NGS) on the bespoke 28 gene panel developed for SMP2. The NGS results are then returned electronically to the local clinical team and patients’ treating oncologist, in a clinically relevant timeframe.

Chief Investigator

Professor Peter Johnson

Contact the SMP2 Team

Email: Precisionmedicine@cancer.org.uk
Telephone: +44 (0)203 4698530