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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.

Contact Information:

Prof Willie Hamilton
01392 726097
W.Hamilton@exeter.ac.uk


Dr Raff Calitri
01392 726047
r.calitri@exeter.ac.uk


More information about this study, what is involved and how to take part can be found on the study website.

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Be Part of Research - Trial Details - Electronic Risk Assessment for Cancer for Patients in General Practice
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Electronic Risk Assessment for Cancer for Patients in General Practice

Not Recruiting

Open to: All Genders

Age: Other

Exeter

Medical Conditions

Cancer

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

01 Jun 2019 21 Jan 2025

Publications

2023 Protocol article in https://pubmed.ncbi.nlm.nih.gov/36940950/ (added 21/03/2023)

Interventional

Intervention Type : Device
Intervention Description : The eRATs are electronic clinical decision support tools embedded into the general practices’ principal clinical system. They work by collating relevant Read-coded symptoms, supplemented by existing routine blood tests already in the GP’s clinical system, which are then assessed for the possibility of cancer using published algorithms developed by Hamilton and colleagues. There are six eRATs of interest to the study (lung, colorectal, oesophago-gastric, bladder, kidney, and ovary) and they are housed within a Macmillan-sponsored Clinical Decision Support Tool. The eRATs have two main ways of working. Firstly, a prompt appears on screen when a patient has a risk of any one of the studied cancers of 2% or higher. Secondly, the clinician may specifically open a ‘symptom checker’ which lists the relevant symptoms of each studied cancer, allowing the patient’s symptoms to be added and the risk of cancer to be (re)calculated.

530 general practices will be randomised 1:1 to receive either the intervention (access to the suite of electronic Risk Assessment Tools; eRATs) or usual practice. The clusters will be practices. There will also be embedded process and health economics evaluations along with a parallel study modelling the impact of eRATs on NHS service delivery.

RandomisationThis is a pragmatic, cluster RCT. The 530 practices will be randomised using a 1:1 ratio into one of two trial arms: usual diagnostic practice (control) and usual diagnostic practice plus access to the suite of Macmillan electronic risk assessment tools (eRATs) (as the intervention), for a total of 265 practices per arm. Randomisation will be remote and web-based, conducted by an independent member of the data team at the Exeter Clinical Trials Unit, overseen by the CTU statistician (not the trial statistician). The sequence of randomisation will be computer generated. To ensure there is balance between the trial arms regarding practices’ propensity to refer patients for cancer investigation, we will minimise the randomisation by two week wait referral rate (the best available proxy) in national tertiles. We will use simple randomisation to allocate the first 50 practices (~10% of the total target), and then apply minimisation by two week wait referral rate, taking into account the previous allocations to inform the minimisation algorithm. To promote allocation concealment, all allocations using the minimisation algorithm will retain a stochastic element.Once the member of the CTU data team has performed the randomisation, they will alert the trial manager (via email or phone call) who will in turn inform the practice of their allocation outcome. Although this randomisation with minimisation approach should make it almost impossible for the study team to predict the trial arm allocation for practices being processed (i.e., interested and undergoing screening), to ensure allocation concealment the last ten practices to be recruited will be randomised simultaneously – i.e., we will delay randomisation until we have ten final practices signed up to the study.

Data collection proceduresAll primary and secondary outcome measures will be available from the cancer registry: applications for data release will be made to NCRAS. Public Health England (NCRAS) have, in principle, assigned us an in-house statistician to support the data collection process. We will be guided by NCRAS but anticipate requesting two data exports. Currently, there is approximately a 12 month time lag in availability of some of the outcome data we require. As a result, our first export will occur at the end of the trial data collection period. Our second export will occur 12 months after that. Data will not contain any personally identifiable information; we will be requesting and collecting depersonalised (pseudo-anonymised) data. The Public Health England Office for Data Release (ODR) guidelines indicate that no legal gateway (e.g., section 251 approval) will be necessary to obtain these data. For each export, data will be securely transferred in accordance with the registry’s policies and placed into a database developed by Exeter CTU situated on secure computer servers. The CTU will ensure the appropriate security measures are in place to comply with ODR and other required regulatory policies.




You can take part if:



You may not be able to take part if:


1. If a practice is planning to merge or restructure over the course of the trial (to the extent that the practice size will change by at least 10%) they will not be permitted to participate


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • University of Exeter
    University of Exeter Medical School Heavitree Road
    Exeter
    EX1 2LU

This information has not yet been provided by the study team. You'll have an opportunity to discuss any risks and benefits that may be associated with this study prior to consenting to taking part.

Dr Raff Calitri
01392 726047
r.calitri@exeter.ac.uk


Prof Willie Hamilton
01392 726097
W.Hamilton@exeter.ac.uk



More information about this study, what is involved and how to take part can be found on the study website.


The study is sponsored by University of Exeter and funded by The Dennis and Mireille Gillings Foundation; University of Exeter; Cancer Research UK.



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Read full details for Trial ID: ISRCTN22560297

Or CPMS 41736

Last updated 05 February 2025

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