A blood test could tell a GP within days whether a patient’s vague symptoms—stomach pain, fatigue, weight loss—are caused by cancer, rather than leaving them waiting months for a diagnosis. Half of all patients eventually diagnosed with cancer first see their GP with non-specific symptoms that could be caused by dozens of conditions. These patients are referred to specialists more slowly and are more likely to be diagnosed at a late stage, when treatment is less effective. The ARMADILO study will test whether multi-cancer blood tests can accurately detect cancer in 9,900 NHS patients with such symptoms, before they are referred to hospital. If the tests work, GPs could use them to fast-track the right patients for urgent investigation, while avoiding unnecessary referrals for those without cancer. The study will also compare two ways of recruiting patients—GP judgement versus automated selection from electronic health records—to see which is faster and more inclusive. A “council of sceptics” and community partners will help ensure the research reaches diverse populations. By 2030, the team aims to produce clear evidence on which tests work, for which patients, and how to roll them out across NHS primary care.
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BACKGROUND Half of patients later diagnosed with cancer attend their NHS GP with non-specific symptoms such as abdominal pain or weight loss, which can be caused by many conditions. It takes longer for these patients to be referred to a cancer specialist, and they are more likely to be diagnosed with late-stage cancer, leading to worse outcomes. The NHS Cancer Programme and James Lind Alliance prioritise research into novel blood tests to select patients with concerning symptoms for urgent cancer investigation. Multi-cancer blood tests could help select patients by detecting the presence of cancer across multiple cancer sites. Efficient primary care studies are required to understand the diagnostic accuracy of multi-cancer tests in patients with symptoms before a referral. OVERALL AIM To accelerate multi-cancer test evaluation in NHS primary care, leading to measurable patient benefit by 2030. HYPOTHESIS Diagnostic accuracy results for multi-cancer tests can be reproduced in a prospective cohort of symptomatic patients attending primary care. OBJECTIVES 1. Set-up an inclusive primary care multi-cancer test evaluation to meet the diverse needs of the public, NHS and commercial developers 2. Ascertain the diagnostic accuracy of multi-cancer tests in patients with non-specific symptoms attending primary care, individually, combined, and with associated clinical data 3. Optimise inclusive recruitment processes and data capture 4. Compare patients recruited using individual GP judgement with those selected using electronic health records data A fifth cross-cutting objective is inclusive leadership development in health technology assessment. METHODS A single-arm multi-centre observational phase II diagnostic accuracy study of complementary multi-cancer tests in 9,900 patients attending NHS primary care with non-specific symptoms (Obj 1&2) An internal pilot study to assess whether study processes are feasible and inclusive, data quality is acceptable, and that data linkages are functional. Study processes will be modified accordingly in consultation with PPIE representatives, community EDI partners, and an independent ‘council of sceptics’ (Obj 3) A Study Within A Trial Data Utility Comparison Study will compare GP-recruited participants with patients selected using electronic health records data to understand if GP recruitment and manual data collection might be supplemented or replaced by automated patient selection and real-time electronic health records analysis (Obj 4) PATIENT AND PUBLIC INVOLVEMENT & EQUALITY DIVERSITY AND INCLUSION We have recruited two PPIE leads and have partnered with Egality Health and the Centre for Research Equity to: 1. Contribute to study oversight 2. Ensure recruitment considers where inequalities currently lie 3. Co-design patient facing materials so they are widely accessible 4. Critically review study processes and suggest modifications 5. Contribute to the development of materials for dissemination TIMELINES: July 2025-June 2030 ANTICIPATED IMPACT AND DISSEMINATION 1. Estimates of diagnostic efficacy for individual and combined multi-cancer tests to inform future effectiveness evaluations 2. The development of methodologies for the evaluation of multi-cancer tests 3. Integrated electronic health records tooling to facilitate recruitment 4. A network of NHS General Practices to accelerate multi-cancer test evaluation 5. Academic and public facing reports and presentations.
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