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Feasibility Study to Investigate Rectal Mucus in Aero-Digestive Tract Cancer.

This study aims to find out if changes in DNA, linked to cancers of the tummy and breathing passages (like lung, bladder, or pancreatic cancer), can be found in mucus collected from the rectum. We're using a special, easy-to-use device called OriCol™. The main goal is to see if this method is possible and if it can pick up these cancer-related signals. We also want to check how comfortable people find using the device and gather more information about this rectal mucus for future research. If successful, this simple test could help find cancers earlier without the need for more invasive procedures.

At a glance

Status
Recruiting
Sponsor
Origin Sciences
Enrolment target
450
Start
01 Dec 2021
Estimated completion
01 Dec 2027

What is this study about?

Imagine your body's inside lining, from your throat all the way to your bowel, and even including organs like your lungs and pancreas. This lining is all connected and shares some similar features because it developed from the same basic cells when you were forming as a baby. Cancers that start in these areas can sometimes shed tiny bits of themselves, including cells and DNA, into the gut. These bits then travel through your digestive system.

This study is exploring whether we can collect these tiny bits of cancer-related DNA and cells from a simple sample of mucus taken from your rectum (the very end of your bowel). We're using a special, easy-to-use device called OriCol™ for this. The main idea is to see if this method is actually possible and if it can reliably find signs of cancers that aren't directly in the bowel, such as lung, bladder, or pancreatic cancer.

Why does this matter? Well, during big health crises like the Covid-19 pandemic, getting traditional cancer tests, like scopes, became much harder. This made it clear that we need simpler ways to check people for cancer, especially in a GP's surgery. This new test could be quick, less uncomfortable than other tests, and could help doctors decide who needs more detailed investigations, potentially finding cancers much earlier.

Key takeaways

  • This study explores a new, simple test for non-bowel cancers.
  • It uses a special device to collect rectal mucus (from your bottom).
  • The aim is to find cancer-related DNA shed from other areas like the lungs or pancreas.
  • It could lead to earlier and less invasive cancer detection methods.
  • Your comfort with the test is an important part of the research.

Who may be eligible?

To join this study, you need to be 18 years old or older and be able to understand and sign a consent form.

However, you won't be able to take part if you have certain problems that might make examining your rectum difficult or uncomfortable. This includes conditions like painful cracks, swollen veins (haemorrhoids) that are causing symptoms, or blockages in your bottom. You also can't join if you’ve had cancer before or if you’ve received treatments like radiotherapy, chemotherapy, or immunotherapy for cancer.

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 over?
  2. Can you understand and sign a consent form?
  3. Do you have any current painful issues or blockages *in or near* your bottom?
  4. Have you ever been diagnosed with cancer before?
  5. Have you had cancer treatments like radiotherapy, chemotherapy, or immunotherapy?
Answer every question to see your result.

What does participation involve?

The study doesn't detail specific visits or very frequent assessments. It focuses on collecting a sample using the OriCol™ device. While the exact duration isn't specified, the core part of your involvement would likely be a single appointment to understand the study, provide consent, and then collect the sample, possibly with instructions for at-home collection. There is no medication involved, and the follow-up would primarily be around how acceptable you found the device.

Potential risks and benefits

Participating in this study might not directly benefit your health immediately, as it's a feasibility study to see if the test works. However, your contribution could help doctors develop new, simpler ways to detect certain cancers in the future, which would benefit many people. The risks are likely very low, mainly involving minor discomfort during the sample collection using the OriCol™ device. You have the right to withdraw from the study at any time without explaining why and without affecting your medical care.

Locations (1)

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

Common questions

What kind of cancers is this test trying to detect?

It's mainly looking for signs of cancers that are not directly in your bowel, such as lung, pancreatic, or bladder cancer, by checking rectal mucus.

What is the 'OriCol™ Sampling Device'?

It's a special, easy-to-use device designed to collect a small sample of mucus from your rectum (the end of your bowel).

Will taking part in this study help me personally?

While it might not directly benefit your immediate health, your participation is very important for research. It could help develop a simpler, quicker way to find cancers for others in the future.

Is the sample collection painful?

The goal is for it to be minimally uncomfortable. The study also wants to find out how comfortable people find using the device.

What happens if they find something in my sample?

This study is primarily for research to see if the method works. It is not designed to give you a personal diagnosis. You should discuss with the study team how they handle incidental findings based on the study protocol.

How to find out more

Ian Daniels, 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 "Feasibility Study to Investigate Rectal Mucus in Aero-Digest…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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