All studies
CompletedNot ApplicableInterventional

Assessment of the impact on chemotherapy decision-making and cost effectiveness of the integration of the digital biomarker test OncoProg into early stage colon cancer treatment pathways

Every year, around 42,000 people in the UK are diagnosed with bowel cancer, with about half caught at an early stage. Following surgery, many patients are offered chemotherapy to reduce the chance of the cancer returning. However, chemotherapy only benefits a small number of these patients, while many experience unpleasant side effects without extra benefit. This study looks at OncoProg, a digital tool that uses computer analysis on tumour samples taken during standard surgery. The tool looks for specific patterns to predict whether chemotherapy is likely to help. Because the study uses tissue that has already been removed, taking part does not involve extra hospital visits, blood tests, or new medications. The results simply give you and your doctor extra information to help you decide together on the best treatment plan for you.

At a glance

Status
Completed
Phase
Not Applicable
Sponsor
Oxford Cancer Biomarkers Ltd
Enrolment target
270
Start
02 Sep 2024
Estimated completion
10 Feb 2026

What is this study about?

Bowel cancer is one of the most common cancers in the UK. When it is found in its early stages (stage 2 or early stage 3), the main treatment is usually an operation to remove the tumour. After surgery, doctors often discuss chemotherapy. Chemotherapy aims to kill any tiny cancer cells that might have been left behind, reducing the chance of the cancer coming back.

However, working out who actually needs chemotherapy after surgery is difficult. Many people are completely cured by surgery alone, meaning chemotherapy would not give them any extra benefit. Because chemotherapy can cause difficult side effects like sickness, severe tiredness, and nerve pain, it is important to avoid giving it to people who do not need it.

Researchers have created a digital tool called OncoProg to solve this problem. It uses artificial intelligence to scan and study digital pictures of your tumour tissue that was already removed during your routine surgery. By analysing cell patterns, it helps doctors see how likely your cancer is to return, and whether chemotherapy is likely to lower that risk.

This study is testing how well OncoProg works within routine care at NHS hospitals in the West Midlands. The goal is to give doctors and patients clearer information so they can make confident, personal choices about their care, while also helping the NHS use its resources wisely.

Key takeaways

  • Tests an artificial intelligence tool called OncoProg to personalise chemotherapy decisions.
  • Aimed at people diagnosed with early-stage bowel cancer.
  • Uses tumour tissue that has already been removed during your normal surgery.
  • No extra hospital visits, blood tests, or experimental medications are required.
  • Helps patients and doctors avoid unnecessary chemotherapy and its side effects.
  • Based at University Hospital Birmingham and partner NHS hospitals in the West Midlands.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with early-stage (stage 2 or early stage 3) colon cancer. To take part, you must be well enough to receive standard chemotherapy if you and your doctor decide it is needed. You must also be receiving care at University Hospital Birmingham or one of its linked NHS sites in the West Midlands.

You will not be able to join if you are pregnant or breastfeeding, or if you have other medical conditions that make standard chemotherapy unsafe for you. You are also not eligible if you received chemotherapy or radiotherapy before having your bowel surgery.

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 been diagnosed with stage 2 or early stage 3 colon cancer.
  3. I have had surgery, but did not have chemotherapy or radiotherapy before my operation.
  4. My doctor considers me well enough to have chemotherapy if it is recommended.
  5. I am not pregnant or breastfeeding.
  6. I am receiving treatment at University Hospital Birmingham or a participating West Midlands NHS hospital.
Answer every question to see your result.

What does participation involve?

Taking part in this study is designed to fit directly into your normal hospital care. Because OncoProg analyses the tissue sample that was already removed during your bowel surgery, you will not need to have any extra operations, blood tests, or scans. There are no trial medications to take, and you will not need any extra hospital visits beyond your normal appointments. Your care team will receive the OncoProg report and discuss the results with you during your standard post-surgery review. Together, you will decide whether chemotherapy is the right path. Your regular NHS follow-up visits will continue as normal until the study completes in May 2026.

Potential risks and benefits

A potential benefit of joining is that the test provides your doctor with more detailed information about your tumour, which can help you make a well-informed decision about chemotherapy and potentially avoid unnecessary treatment. There are no direct physical risks, as the study only uses tumour tissue that has already been removed during your planned operation. Taking part is completely voluntary, and you can withdraw at any time without giving a reason and without your NHS care being affected.

Locations (4)

  • University Hospital Birmingham
    Approximate
    Birmingham, England
  • Walsall Manor Hospital
    Approximate
    Walsall, England
  • The Royal Wolverhampton NHS Trust
    City only
    Wolverhampton, England
  • Worcestershire Royal Hospital
    Approximate
    Worcester, England

Common questions

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

No. The OncoProg test uses the tumour tissue that the hospital has already collected during your standard surgery.

Does the computer make the decision about my chemotherapy?

No. The OncoProg tool only provides extra information to your doctor. The final decision about whether to have chemotherapy is always made between you and your healthcare team.

Will taking part require extra hospital visits?

No. Everything is carried out alongside your routine NHS appointments, so you will not have to make extra trips to the hospital.

Does it cost anything to take part?

No. The study is funded through the Department of Health and Social Care, so there are no costs to you.

What happens if I decide not to take part?

Taking part is entirely your choice. If you decide not to join, you will still receive the standard high-quality NHS care and treatment recommended by your doctor.

How to find out more

Susan Fotheringham

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

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