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Not yet recruitingOBSERVATIONAL

CLinical Evaluation Of a comPuter Algorithm To Report BreAst cAncers (CLEOPATRAA)

This study, called CLEOPATRAA, is evaluating a new computer program named QPORB. This program analyses digital images from breast cancer biopsies. The main goal is to see if QPORB can accurately grade breast cancers and identify their specific types, which helps doctors choose the best treatment. Researchers also want to find out if using this technology could save time and money for the NHS. This is not an experimental treatment, but rather a tool to help doctors. Patient samples that are already being processed for routine diagnosis will be used, without needing extra tests or changes to your care. The study will also collect long-term information to understand treatment responses better.

At a glance

Status
Not yet recruiting
Sponsor
The Leeds Teaching Hospitals NHS Trust
Enrolment target
800
Start
01 Dec 2023
Estimated completion
30 Nov 2034

What is this study about?

The CLEOPATRAA study is looking at a new computer program called QPlasia OncoReader Breast (QPORB). This program is designed to help doctors by analysing digital pictures taken from breast cancer biopsies. When someone has a breast biopsy, a small sample of tissue is taken and looked at under a microscope. Now, with digital imaging, these microscope slides can be turned into digital pictures.

QPORB looks at these digital pictures, just like a pathologist (a doctor who specialises in diagnosing diseases by looking at tissue samples) would. It aims to identify if cancer is present, how aggressive it appears (this is called 'grading'), and its specific type (known as 'molecular subtyping'). Knowing the grade and type of cancer is really important because it helps doctors decide on the most effective treatment plan for each patient.

This study is basically a 'real-life test' of QPORB. The researchers want to see how well it works alongside the usual ways doctors diagnose breast cancer in hospitals. They're also trying to figure out if this technology could save time and resources for the NHS and ultimately lead to better and faster diagnoses for patients. There's also a plan to follow up with patients over 5 to 10 years to learn more about how different cancers respond to treatments, which could help improve future care.

Key takeaways

  • It's a study testing a computer program to diagnose breast cancer more accurately.
  • No changes to your current medical care or treatment.
  • It uses existing biopsy images, so no extra tests are needed.
  • Aims to improve breast cancer diagnosis and treatment for future patients.
  • Researchers will also see if the program can save time and money for the NHS.
  • Long-term data will be collected to understand treatment responses better.

Who may be eligible?

You might be included in this study if you are a patient aged between 16 and 110 years old and have had a breast biopsy processed at the pathology laboratory in St James's University Hospital (SJUH) or Leeds Teaching Hospitals NHS Trust (LTHT).

However, you would not be included if your breast biopsy sample is for a type of cancer that is not a carcinoma (the most common type of breast cancer), such as sarcomas or malignant phyllodes tumours, or if the cancer did not originally start in the breast.

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. Are you between 16 and 110 years old?
  2. Did you have a breast biopsy at SJUH or LTHT?
  3. Is your biopsy for a primary breast carcinoma (the most common type of breast cancer)?
  4. Is your cancer clearly from the breast and not from another part of the body?
Answer every question to see your result.

What does participation involve?

If you are eligible for this study, you will not have to do anything extra. This study uses samples that are already being processed as part of your routine diagnostic care. Your doctors will continue with your usual treatment plan. The computer program will analyse a digital image of your biopsy sample in the background, without requiring any additional tests or changes to your medical care or appointments. Researchers will then compare the computer's findings with the results from your hospital's standard diagnostic procedures. The study will also collect information about your health over 5 and 10 years, using information from your medical records, to understand long-term outcomes and treatment responses.

Potential risks and benefits

Since this study uses existing medical samples and does not involve any changes to your treatment or additional procedures, there are no direct risks to you. There are also no direct benefits to you as an individual, but the potential benefit is that the study could lead to improved and faster breast cancer diagnosis and treatment for future patients in the NHS. You do not need to do anything to participate, but if you have any concerns or wish to discuss if your routinely collected data can be used for research, you should speak with your healthcare team.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • St James's University Hospital, Leeds Teaching Hospitals Trust
    Verified postcode
    Leeds, United Kingdom

Common questions

What is the purpose of this study?

This study is testing a new computer program to see if it can accurately help diagnose and classify breast cancer from biopsy images, aiming to improve future patient care.

Do I need to do anything if I'm part of this study?

No, you don't need to do anything. Your biopsy samples are looked at by the computer program as part of routine hospital processes, with no extra steps for you.

Will this study change my treatment?

No, this study will not change your diagnosis or treatment plan. It is testing a new tool that might help doctors in the future.

Is this a new type of experimental treatment?

No, this is not an experimental treatment. It's a study of a computer program designed to help doctors with diagnosis, not a new therapy for patients.

Will my personal information be kept private?

Yes, all data used in research studies is handled with strict confidentiality to protect your privacy.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "CLinical Evaluation Of a comPuter Algorithm To Report BreAst…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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