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CompletedObservational

Pathology Artificial-Intelligence Clinical Evaluation Study

The PACES study is exploring how artificial intelligence (AI) computer programs could assist NHS doctors in caring for people with bowel cancer. When you have a routine biopsy or surgery, tissue samples are sent to a laboratory to be checked under a microscope. In this study, digital photographs of these routine samples are analysed by AI tools. To ensure your care remains completely safe, your doctors will agree your treatment plan as normal first. Only afterwards will researchers show your medical team the computer results. Doctors will then report whether the AI's findings might have helped personalise your care further. Taking part will not change your cancer treatment, and you will not need any extra appointments, blood tests, or procedures. While joining will not benefit you directly, it may help the NHS introduce safe technology to improve cancer care for others in the future.

At a glance

Status
Completed
Sponsor
University of Oxford
Enrolment target
170
Start
01 Oct 2024
Estimated completion
01 Oct 2026

What is this study about?

When doctors suspect bowel cancer, they remove a tiny piece of tissue called a biopsy, or look at tissue removed during surgery. Pathologists—specialist doctors who study disease in tissue—examine these samples under a microscope to confirm the diagnosis and help choose the best treatment. As laboratories become busier, scientists are testing whether computer programs powered by artificial intelligence (AI) can assist pathologists by analysing tissue images quickly and accurately.

The PACES study tests three new AI programs designed at the University of Oxford. If you take part, digital photographs of the tissue samples already collected during your standard NHS care will be safely shared with the research team. The AI programs will examine these digital pictures to look for patterns and suggest possible diagnosis or treatment insights.

Your actual medical care will not depend on these computer programs. Your healthcare team will first meet and decide your real-life diagnosis and treatment using their normal expertise. Only after this decision is set in stone will they look at the AI results. Doctors will then answer whether having the computer's input earlier would have changed or supported their advice. This helps researchers prove whether AI tools are truly helpful and reliable in real hospital settings before they are used more widely.

Key takeaways

  • PACES is testing how AI computer tools can help doctors assess bowel cancer tissue samples.
  • The study uses digital pictures of tissue samples you have already provided during standard NHS care.
  • There are no extra hospital appointments, medications, or surgical procedures involved.
  • Your doctors make all treatment decisions as normal before reviewing any AI suggestions.
  • Participation carries very low risk and aims to improve bowel cancer care for future NHS patients.

Who may be eligible?

You may be able to join this study if you are 18 or older and have suspected or confirmed bowel cancer (also called colorectal adenocarcinoma) at any stage. You must be an NHS patient who is scheduled to have cancer treatment, such as surgery, chemotherapy, radiotherapy, targeted biological treatments, or supportive palliative care.

You will not be able to participate if you have had chemotherapy and radiotherapy combined in the 12 months before your cancer biopsy was taken. You may also be unable to join if you have another significant health condition that, in the study doctor's opinion, could affect the study results or your safety.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

  1. I am aged 18 or older.
  2. I have suspected or confirmed bowel cancer (colorectal adenocarcinoma) of any stage.
  3. I am scheduled to have cancer treatment (such as surgery, chemotherapy, radiotherapy) or palliative care.
  4. I have not had combined chemotherapy and radiotherapy for this cancer in the past 12 months before my biopsy.
  5. I am willing to allow my routine NHS tissue images to be used for research.
Answer every question to see your result.

What does participation involve?

Taking part in this study is very straightforward because it happens quietly in the background of your usual care. You do not need to attend any extra hospital visits, fill out lengthy questionnaires, or take new medications.

With your permission, the research team will simply access digital copies of the tissue slides that the NHS has already prepared from your biopsy or surgery. These images are labelled with a code rather than your name to protect your privacy. Your clinical team will make all your medical decisions as usual. The entire trial is running between 2024 and 2028, but your involvement simply covers the review of the tissue already taken for your current diagnosis.

Potential risks and benefits

There is no direct medical benefit to taking part, as your doctors will not use the AI results to plan your treatment. However, your participation could help researchers prove whether AI can help future NHS patients receive faster, more personalised cancer care. The physical risks are extremely low because you will not undergo any extra procedures, blood tests, or treatments. Your medical team will handle your records securely and confidentially. You are entirely free to withdraw from the study at any time, and doing so will never affect your standard NHS care or your relationship with your doctors.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Oxford University Hospitals NHS Foundation Trust
    City only
    Oxford, England

Common questions

Will taking part delay my cancer treatment?

No. Your treatment will continue on its usual schedule without any delays, because the AI analysis runs separately in the background.

Will an AI computer be deciding my treatment?

No. Your treatment decisions are made entirely by your human NHS medical team. The doctors only see the AI results after your treatment plan has already been decided.

Do I need to give any extra tissue or blood samples?

No. The study only uses digital photographs of the tissue samples that the hospital has already taken as part of your standard NHS care.

Will my personal details be kept private?

Yes. Digital images of your slides are pseudonymous, which means personal details like your name are replaced with a secure code before analysis.

What happens if I change my mind later?

You can leave the study at any point without giving a reason. Your standard NHS treatment and care will carry on exactly the same.

How to find out more

Chen-Chun Pai

Always speak to your GP or specialist before deciding to take part in a study.

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