Accelerated community multi cancer diagnostic evaluation platform
| ISRCTN | ISRCTN12070026 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN12070026 |
| Integrated Research Application System (IRAS) | 348402 |
| Central Portfolio Management System (CPMS) | 64367 |
| National Institute for Health and Care Research (NIHR) | 169172 |
| Sponsor | University of Oxford |
| Funder | National Institute for Health and Care Research |
- Submission date
- 11/08/2026
- Registration date
- 23/09/2026
- Last edited
- 23/09/2026
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
Many people visit their GP with symptoms such as abdominal pain, loss of appetite, bloating, nausea or unexplained weight loss. These symptoms are common and are often caused by conditions other than cancer, but they can sometimes be a sign of cancer. Because these symptoms can have many different causes, it can be difficult for GPs to decide which patients should be referred to hospital for specialist cancer tests.
Multi-cancer blood tests are new types of blood tests that look for signals associated with several different types of cancer. They could potentially help GPs decide which patients need further investigation. Before these tests can be used routinely in the NHS, researchers need to understand how accurately they identify people who do and do not have cancer.
The ARMADILO study aims to assess several multi-cancer blood tests in people aged 50 years or over who are having NHS blood tests because they have symptoms that could have a number of causes, including cancer. The researchers will compare the multi-cancer test results with information from participants' NHS health records to assess how accurately the tests identify people who are diagnosed with cancer.
This is an observational study, so taking part will not change a participant's medical care. The multi-cancer test results will not be given to participants nor their GPs and will not be used to make decisions about care because the accuracy of the tests is not yet known. Participants will continue to receive their usual NHS investigations and care.
Who can participate?
People may be able to take part if they:
1. Are aged 50 years or over
2. Are having a blood test in NHS primary care to investigate at least one of the following symptoms: abdominal pain, loss of appetite, bloating, nausea or weight loss
3. Are willing and able to give informed consent; and
4. Are willing and able to provide a blood sample for the research.
People cannot take part if they have already joined the ARMADILO study, or if they have had certain invasive cancers or cancers of the blood, bone marrow or lymphatic system, or definitive treatment for these cancers, within the previous three years. Some treatments, such as adjuvant hormone therapy, are allowed.
What does the study involve?
People who decide to take part will have one study visit. Where possible, this will take place at the same time as their usual NHS appointment for a blood test. In some areas, the study blood sample may instead be taken at the participant's home or another suitable community location.
Participants will be asked to give one blood sample of up to 80 ml, answer some questions about themselves and their health, and give permission for researchers to obtain information from their medical records, including GP, hospital and central NHS records.
There are no further routine study visits. Participants' health records will be followed for at least 12 months to find out whether they are diagnosed with cancer. Participants will also be asked for permission for their records to potentially be followed for up to 5 years to investigate longer-term cancer and non-cancer outcomes.
The donated blood will be used to assess different multi-cancer tests. Participants and their GPs will not receive the results of these tests.
Some participants may also be invited to take part in an interview about their experience of the study. This will help the researchers understand how acceptable and practical the study procedures are and whether there are barriers that make it more difficult for some groups of people to take part.
What are the possible benefits and risks of participating?
There is no expected direct medical benefit to people who take part. In particular, taking part will not provide an earlier diagnosis or additional information about the cause of a participant's symptoms because the multi-cancer test results will not be returned. Participants' normal NHS investigations and care will continue regardless of whether they take part.
The information collected may help researchers determine whether multi-cancer blood tests could be useful in the NHS in the future. If suitable tests are identified and subsequently shown to work in further studies, they could potentially help GPs decide which patients need specialist cancer investigations and contribute to earlier diagnosis for future patients.
The main physical risks are those associated with having blood taken. These include temporary discomfort, bruising or light-headedness and a small risk of infection. Where possible, the research blood will be collected at the same time and using the same needle as the participant's routine NHS blood test, although in some circumstances an additional blood-taking appointment may be needed.
Where is the study run from?
The study is being led by researchers at the University of Oxford, Nuffield Department of Primary Care Health Sciences (UK). Recruitment will take place across approximately 132 primary care sites. The study is sponsored by the University of Oxford and is coordinated through the Oxford Collaborative Clinical Trials Unit.
When is the study starting and how long is it expected to run for?
October 2026 to September 2030
Who is funding the study?
The study is funded by the National Institute for Health and Care Research (NIHR), Efficacy and Mechanism Evaluation programme (UK).
Who is the main contact?
ARMADILO Study Team, armadilo_pcctu@phc.ox.ac.uk
Contact information
Principal investigator, Scientific
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
 ORCID ID |
0000-0003-0661-7362 |
|---|---|
| Phone | +44 (0)1865 289300 |
| brian.nicholson@phc.ox.ac.uk |
Public
Clinical Trials Unit - ARMADILO Study
Nuffield Department of Primary Care Health Sciences
University of Oxford
Radcliffe Observatory Quarter
Woodstock Road
Oxford
OX2 6GG
United Kingdom
| armadilo_pcctu@phc.ox.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational cohort study |
| Secondary study design | Cohort study |
| Scientific title | AcceleRated community Multi cAncer DIagnostic evaLuatiOn platform (ARMADILO) |
| Study acronym | ARMADILO |
| Study objectives | Primary objective: To evaluate the overall performance of individual multi-cancer tests in symptomatic patients attending primary care for newly-diagnosed invasive cancer Secondary objectives: 1. To evaluate the performance of individual multi cancer tests in symptomatic patients attending primary care for newly-diagnosed invasive cancer, by test result, cancer type, and cancer stage 2. To evaluate the performance of individual multi cancer tests in symptomatic patients attending primary care for newly-diagnosed invasive cancer, by patient characteristics and symptom cluster 3. To calculate the performance of combinations of multi-cancer tests in symptomatic patients attending primary care for newly-diagnosed invasive cancer, by test, result cancer type, cancer stage, patient characteristics, and symptom cluster 4. To test whether sequencing multi-cancer tests in symptomatic patients attending primary care leads to superior performance accuracy for newly-diagnosed invasive cancer to individual multi-cancer tests 5. To evaluate that recruitment is inclusive and representative of the eligible practice population (internal pilot) 6. Use qualitative methods to explore how practice staff and patient participants experience the study processes, including recruitment and participation 7. To compare the characteristics of participants that are selected by GPs with those that are identified from simple or risk algorithm searches of the electronic health record Exploratory objectives: 1. To investigate if the addition of patient characteristics, symptoms, and blood test results optimise the performance of the multi-cancer tests 2. To model the potential the consequence of delayed ascertainment of the reference standard on cancer stage 3. To investigate the impact of pre-analytical factors on multi-cancer test performance 4. To assess the potential cost-effectiveness of adding the test to the cancer diagnostic process |
| Ethics approval(s) |
Approved 22/09/2026, North West - Greater Manchester (GM) South Research Ethics Committee (HRA RES Centre Manchester, 3rd Floor, 3 Piccadilly Place, London Road, Manchester, M1 3BN, United Kingdom; +44 (0)207 104 8014; gmsouth.rec@hra.nhs.uk), ref: 26/NW/0231 |
| Health condition(s) or problem(s) studied | Cancer |
| Methodology | This is a single-arm prospective observational multicentre cohort study. Potential participants will be identified either opportunistically when they see their GP or through regular searches of recent presentations at the GP practice. Eligible patients will be forwarded the Participant Information Leaflet and consent will be documented prior to any study blood draw and baseline data collection taking place. Participants will be asked to donate up to 80 ml of blood and this blood will be collected as an addition to their NHS phlebotomy appointment however a separate study only blood draw will be permitted. Some baseline data (e.g., smoking status) will also be collected from participants. Participants will be asked to consent to their medical records being followed up via data linkage for a maximum of 5 years after they enter the study in order to ascertain the cause of their symptoms (cancer yes/no) at 12 month timepoint. Participants will have no direct follow up after the initial study visit. Longer data linkage is requested in the event 12-month timepoint analysis prompts the need for further follow up. Multi-cancer diagnostic testing will be run retrospectively and results will not be returned to either participants or their GP. This will be explicitly stated as part of the Participant Information Leaflet. Participants will follow standard NHS pathways for any necessary investigations. As part of our commitment to ensuring inclusive recruitment we will conduct an internal pilot and assess recruitment at 9 months to ensure participants are representative of the practice population. Study protocol and participant facing materials may be amended based on the findings of the internal pilot. Following recruitment completion a retrospective Data Utility Comparison Study (DUCkS) will be conducted to assesses the future feasibility of data driven recruitment. |
| Intervention type | Other |
| Primary outcome measure(s) |
|
| Key secondary outcome measure(s) |
1. The performance of individual multi-cancer tests in symptomatic patients attending primary care for newly-diagnosed invasive cancer, by test result, cancer type, and cancer stage, measured using positive predictive value, negative predictive value, sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, and area under the curve at 12 months post recruitment |
| Completion date | 01/09/2030 |
Eligibility
| Participant type(s) | |
|---|---|
| Age group | Mixed |
| Lower age limit | 50 Years |
| Upper age limit | 100 Years |
| Sex | All |
| Target sample size at registration | 9000 |
| Key inclusion criteria | 1. Willing and able to give informed consent for participation in the study 2. Aged 50 years or above 3. Having a blood test in NHS primary care for the investigation of at least one of the following non-specific symptoms: abdominal pain, appetite loss, bloating, nausea, weight loss 4. Willing and able to donate a blood sample for research Study participants for the qualitative component: 1. Practice staff involved in delivering the study at sites including practice managers, GPs, nurses, receptionists and other practice staff 2. Patient participants: same criteria as for main study, but interviews may also include carers and/or family members involved in their care |
| Key exclusion criteria | 1. Previously enrolled in this study 2. A history of invasive or haematological malignancy (cancers affecting blood, bone marrow and lymphatic system) diagnosed within the past 3 years 3. Has undergone definitive treatment for invasive or haematological malignancy in the past 3 years (adjuvant hormone therapy is permissible in this context) |
| Date of first enrolment | 15/10/2026 |
| Date of final enrolment | 01/10/2028 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centres
Freeman Road
High Heaton
Newcastle upon Tyne
NE7 7DN
England
Beckett Street
Leeds
LS9 7TF
England
Oxford Road
Manchester
M13 9WL
England
Wolverhampton Road
Heath Town
Wolverhampton
WV10 0QP
England
Colney
Norwich
NR4 7UY
England
80 Newark Street
London
E1 2ES
England
Westminster Bridge Road
London
SE1 7EH
England
Tremona Road
Southampton
SO16 6YD
England
Guildford
GU2 7XX
England
Marlborough Street
Bristol
BS1 3NU
England
Barrack Road
Exeter
EX2 5DW
England
Infirmary Square
Leicester
LE1 5WW
England
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|
Editorial Notes
11/08/2026: Study's existence confirmed by the NIHR.
