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RecruitingOBSERVATIONAL

Triple Assay of Rectal Mucus in the Diagnosis of Colorectal Cancer

This study is investigating a new 'Oricol Test' designed to help diagnose bowel cancer and significant polyps. The test works by looking at a sample of mucus taken from your bottom (rectum). Researchers are trying to identify specific patterns in this mucus related to genes, bacteria, and other tiny changes that can signal bowel cancer or growths called adenomas. The study focuses on people in the UK who have been referred for urgent checks for suspected bowel cancer. The main goals are to confirm these patterns, find new ones, and see how well the test can identify people who have cancer or high-risk polyps, as well as those who don't. Ultimately, this research hopes to find a simpler and more efficient way to detect bowel problems early.

At a glance

Status
Recruiting
Sponsor
Origin Sciences
Enrolment target
6,600
Start
01 Nov 2024
Estimated completion
01 Apr 2027

What is this study about?

This study is really important because it's looking for new and better ways to find bowel cancer and pre-cancerous growths, called polyps, more quickly and easily. When doctors suspect someone might have bowel cancer, they often refer them for urgent tests, like a colonoscopy, which involves a camera looking inside the bowel. While very effective, these can be uncomfortable and there's a waiting list for them.

This research is focused on developing a special 'Oricol Test' that examines a small sample of mucus taken from the rectum, which is the last part of your bowel. Think of it like taking a swab. The scientists are looking for tiny clues within this mucus – things like specific genetic changes, different types of bacteria, and other markers that might indicate if cancer or a high-risk polyp is present. They want to see if these clues match what they already know and if they can find new clues too.

The overall aim is to see how well this Oricol Test can accurately tell the difference between people who have bowel cancer or a significant polyp, and those who don't. If successful, this test could potentially help doctors decide who needs an urgent colonoscopy and who doesn't, making the diagnostic process more efficient and less invasive for some patients.

Key takeaways

  • This study investigates a new test for bowel cancer using a mucus sample.
  • It aims to find new, easier ways to detect bowel cancer and polyps early.
  • Participation involves providing a rectal mucus sample; no new medications.
  • The test is for research and won't change your personal diagnosis or treatment.
  • You must be 18+ and on the urgent suspected cancer pathway to join.
  • You can withdraw from the study at any time.

Who may be eligible?

To join this study, you need to be at least 18 years old. You must also have been referred by your GP to the 'urgent suspected cancer' pathway for bowel checks during the time the study is running. It's really important that you willingly agree to take part and sign a consent form after understanding everything about the study.

There are some reasons why you wouldn't be able to join. For instance, if you're unable to have a simple finger examination of your bottom (called a digital rectal examination or DRE). Also, if you have certain conditions around your bottom area that would make this examination difficult or uncomfortable, or if you've recently had radiotherapy to that area, you wouldn't be eligible.

Finally, if you are pregnant or think you might be pregnant, you wouldn't be able to participate in this study.

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 18 years old or older?
  2. Have you been referred by your GP for urgent bowel checks?
  3. Are you able to have a simple finger examination of your bottom?
  4. Are you not pregnant or suspect you might be pregnant?
Answer every question to see your result.

What does participation involve?

If you decide to take part, the main thing you'd do is provide a small mucus sample from your rectum using the Oricol Test. This is similar to a swab. The doctors conducting the study will explain exactly how this is done. You'll also need to have been referred for urgent bowel checks already, so your usual care pathway for these checks will continue. The study itself doesn't involve extra visits beyond what's needed for your primary care and referral to the urgent pathway. You won't be given any new medications specifically for this study. The total duration of your participation would mainly involve the single sample collection and your continued involvement in the usual urgent cancer investigation pathway.

Potential risks and benefits

Taking part in this study could potentially help advance our understanding of bowel cancer detection, which might lead to better diagnostic tools for everyone in the future. For you personally, there's no direct medical benefit as the test is currently for research only and won't change your immediate diagnosis or treatment plan. The main risk involves the collection of the mucus sample, which might cause some minor, temporary discomfort, similar to a routine rectal exam. You have the right to withdraw from the study at any time without giving a reason, and this will not affect your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Shrewsbury & Telford NHS Foundation Trust
    Verified postcode
    Telford, United Kingdom· Recruiting

Common questions

What is the Oricol Test?

It's a new test that looks at a mucus sample from your bottom to find signs of bowel cancer or pre-cancerous growths (polyps).

Will this test tell me if I have cancer?

No, this test is for research only. Your doctors will still use existing methods to diagnose your condition. The study won't change your personal medical care.

Is the test painful?

Collecting the sample might cause some minor, temporary discomfort, similar to a standard rectal exam by a doctor.

Who is paying for this research?

The study is sponsored by the company developing the Oricol test, called GENEDNA LTD.

Can I stop participating if I change my mind?

Yes, you can withdraw from the study at any time without it affecting your medical care.

How to find out more

Jon Lacy-Colson, FRCS

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 "Triple Assay of Rectal Mucus in the Diagnosis of Colorectal …" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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