Summary
Improving the proportion of cancers diagnosed at an early stage is one of the Cancer Ambitions set out in the NHS Long-Term Plan.
The Galleri test is a multi-cancer early detection (MCED) blood test for use in asymptomatic individuals with the aim of detecting cancers at an earlier stage. The NHS Galleri research trial is currently being conducted in NHS England until 2026, with planned, interim trial results expected in Spring/Summer 2024. If the trial results meet the agreed success criteria, then NHS England will launch an interim, implementation pilot which would extend provision of the test to up to one million people from mid-2024.
The Health and Social Care Delivery Research (HSDR) Programme is looking to commission a research team to conduct an evaluation alongside the roll-out of the interim implementation pilot in England. Subject to successful commissioning, this pilot is expected to commence during the summer of 2024. Funding for the evaluation will be dependent on the roll-out of the pilot. Successful applicants will be expected to contract, and start work, rapidly and to report meaningful, intermediate, emerging results early in the contract period.
It is expected that the research, funded through this call, will ultimately increase the evidence base to understand the feasibility, acceptability, uptake, experience, workload and impact of such a service provision change and underpin any potential business case to support wider roll out.
Background
The Galleri test was developed by GRAIL, a healthcare company focused on early cancer detection. The ongoing NHS Galleri trial, entirely funded by GRAIL, is being managed and delivered by Cancer Research UK and the King’s College London Cancer Prevention Trials Unit. The trial is investigating the effectiveness of the Galleri test in diagnosing up to 50 cancer types. The trial involves recruiting 140,000 volunteer participants, aged 50 or older, across eight regions of England, and is assessing the use of the test in asymptomatic individuals. All participants have a blood draw, with half (70,000) receiving a Galleri test in the intervention group and half having no test in the control group. The primary outcome for the trial is the incidence rate of stage III and IV cancers diagnosed in the intervention compared with the control group, for those cancers which are routinely staged.
The Galleri MCED blood test employs genetic sequencing to detect potential signals of cancer. The assay is combined with a machine learning- based classification algorithm that identifies patterns predictive of cancer and indicative of the potential cancer site of origin. Results from an earlier, case-control study indicated that it could identify signals for more than 50 types of cancer, before symptoms occur, including cancers that are typically difficult to identify early (e.g. head and neck, ovarian, pancreatic, lung). The test sequences circulating cell-free DNA (cfDNA) and uses this information to predict the most likely site(s) within the body, that potential cancer signals originate from. The Galleri MCED blood test predicts up to two Cancer Signal Origins by comparing methylation patterns with predictive signatures from 21 possible Cancer Signals Origins. Trial participants with positive detected cancer signals are then referred to NHS services for further diagnostic testing focused on Cancer Signal Origin sites.
Scope
What is the feasibility, acceptability, and patient and service impacts of the use of the Galleri MCED blood test as a cancer screening tool in England?
Some specific areas of interest have been identified:
Evaluating whether the pilot service achieves anticipated patient outcomes and replicates results of the trial
- What was the impact of this service on cancer incidence; how many cancers (primary tumour sites) were diagnosed through the service (in both patients with a positive and negative Galleri MCED blood test result)?
- How did this service deliver in terms of detecting cancer at an earlier stage, and in which cancers (primary tumour location) did the earlier diagnosis rate impact the most?
- Did the service identify more cancers at an earlier stage compared with matched/similar areas not delivering the service?
- What is the conversion rate of positive test results detected by the Galleri MCED blood test (from both primary and secondary site indications)?
- What is the time from test and test result to (1) establishing a cancer diagnosis (ruled in or ruled out) and (2) treatment?
- What is the ongoing care and support for patients with a positive test result but no initial cancer diagnosis?
Understanding the impacts of the pilot service on wider system demand, capacity and resources in the short and longer-term
- What is the impact of this service on Non-Specific Symptoms (NSS) referrals and on Cancer referral type (e.g. the number of Urgent Suspected Cancer or screening referrals to secondary care)?
- How much resource (e.g. time, staffing, costs) is required in primary and secondary care to run this service?
- What is the process for sharing findings with patients and the time spent/impact on GP and specialist consultations in the new pathway?
- What are the diagnostic pathways for patients following their Galleri MCED blood test, either positive or negative (in those with, and without, a cancer diagnosis), and how many other ongoing tests do patients receive?
- How are cancers diagnosed, through this service, treated (and does this differ from usual treatment for clinically detected cancers at the same stage)?
- What are the diagnostic pathways for patients following their Galleri MCED blood test either positive or negative (in those with, and without, a cancer diagnosis), and how many ongoing diagnostic tests/interventions do patients receive?
Evaluating whether the pilot service is being implemented as intended
- How does the National Operations Service work together with secondary care to deliver this model of service delivery, refer patients, and ensure ongoing care for patients?
- What are the barriers and enablers for setting up new phlebotomy services and what resources (e.g. facilities, equipment, staffing, training etc) are required to set up a phlebotomy service?
- How do staff feel about the roll-out of this service encompassing preparation, training and resources?
- How does the service perform against pathway standards as set out in the standard protocol?
- What approaches have Cancer Alliances taken in implementing their local pilots (bio sampling and NSS pathways)?
Understanding engagement with, and barriers to, patient uptake of the test
- How were patients made aware of the new test (channels and formats of communication) and mechanisms for raising concerns?
- What are the barriers or enablers for patients engaging with the service?
- What is the patient drop off through the pathway?
- How are patients targeted, how effective are different engagement strategies (nationally and locally)?
- What is the uptake rate for the Galleri MCED blood test appointment? Is it lower/higher than expected?
Evaluating whether the pilot service has been successful in addressing unwarranted variation in health outcomes for different cancer types
- How do cancers, diagnosed through this service, differ from national proportions of cancer incidence and staging?
- Does test uptake and diagnosis vary by demographics and patient characteristics?
- What is the impact of the Galleri MCED blood test on reducing unwarranted variation in stage of diagnosis across different patient characteristics and geographies, and cancer types?
Understanding patients’ perception of the pilot service and its offer; their understanding of their results and any ongoing care
- How did patients feel about the ease of booking and access to an appointment for a Galleri MCED blood test and any follow-on services?
- Did patients and families feel they had the right tools and support to make informed choices?
- Do patients understand what the test is, why they were invited, what the results told them, and what the next steps were?
- What impact does the service have on patients' well-being and quality of life?
Understanding the potential unintended consequences associated with this pilot service
- How does this service impact patient behaviour and intent to engage with, and uptake, with other, wider, national screening programmes?
- Are cancer conversion rates in this real-world, pilot service implementation, higher or lower than those observed in the trial?
- Does the service detect any incidental findings (e.g. other diagnoses)?
Proposed study design
Proposals are highly likely to be mixed-methods studies led by a team with a track record in national, multi-site, evaluations of complex organisational interventions, encompassing a wide range of qualitative and quantitative, methodological expertise, including experience in accessing, analysis and linkage of routine datasets. The team should have experience of successful engagement with national and local health service decision-makers, digital service providers, staff, and patients. We are looking for a well-designed research study, likely compromising multiple related work packages covering the breadth of the call scope, with strong theoretical grounding, to deliver robust national and international learning, strengthen the evidence base and provide actionable learnings to inform potential wider roll-out of one, or more, new service models.
All applicants are encouraged to contact NHS England to discuss their proposed application. Applicants are encouraged to contact NHS England early on in the development of their application via email: Charlotte.Graham14@nhs.net