RecruitingNAINTERVENTIONAL

Concordance of Imaging and Pathology Diagnosis of Extranodal Tumour Deposits

This study, called COMET, is for people with suspected bowel cancer (colon or rectum) who are having surgery. It aims to see if using special mapping during scans can help doctors find tiny cancer spots, called extranodal tumour deposits, more accurately when they examine tissue samples after an operation. These deposits can be important for understanding how the cancer might behave. Radiologists will identify these deposits on pre-surgery scans and share this information with pathologists, who then look at the removed tissue. The goal is to improve how well imaging and lab tests match up, which could help guide treatment decisions and give patients a clearer picture of their health. Patients will receive standard care and follow-up for five years.

At a glance

Status

Recruiting

Phase

Sponsor

Imperial College London

Enrolment target

200

Start

16 Oct 2017

Estimated completion

01 Dec 2031

Adenocarcinoma of the Rectum

What is this study about?

This study, called COMET, is exploring a new way to get a more accurate picture of bowel cancer, specifically a type called adenocarcinoma of the rectum. When people have bowel cancer, sometimes very small clusters of cancer cells, known as 'extranodal tumour deposits', can be found outside the main tumour. These deposits are tiny and can be tricky to find.

The main idea behind this study is to see if we can improve how well doctors find these tiny cancer spots. Currently, doctors use scans before surgery and then examine the removed tissue afterwards. This study will add a step: radiologists (doctors who specialise in scans) will carefully look at pre-surgery scans to identify any suspicious areas that might be these tumour deposits. They will then share this detailed 'map' with pathologists (doctors who examine tissue samples) who are looking at the tissue removed during surgery. The hope is that having this extra information from the scans will help pathologists find these deposits more reliably in the tissue samples.

Improving how accurately we find these deposits is important because it can affect how doctors understand the cancer and plan the best treatment. It might also help give you more precise information about your specific situation and what to expect in the future. All patients in the study will continue to receive the standard care and follow-up at their local hospital for five years, just as they would normally.

Key takeaways

Study aims to improve detection of tiny cancer spots (tumour deposits) in bowel cancer.
Compares scans with lab tests to see if mapping helps find these spots more accurately.
You will receive standard medical care, no new treatments or tests.
No extra hospital visits or medications are required.
Information from your routine scans and surgery will be used.
Follow-up for 5 years is part of your normal care.

Who may be eligible?

You might be able to join this study if you are at least 16 years old and have been diagnosed with suspected bowel cancer in your colon, sigmoid colon, or rectum. This diagnosis needs to be confirmed by a biopsy. You also need to be having surgery to remove the cancer, and your doctors must have been able to assess the cancer's spread using scans.

Whether you are having surgery right away or have had treatment like chemotherapy or radiotherapy before surgery, you could still be eligible. It's important that you've had initial scans to check the cancer's stage, and if you've had prior treatment, you also need to have had scans after that treatment.

However, you cannot take part if your cancer has come back after previous treatment, if you have more than one unrelated tumour at the same time, or if you are under 16. You also need to be able to understand the study and agree to take part.

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.

Are you 16 years or older?
Do you have suspected bowel cancer in your colon, sigmoid colon, or rectum?
Are you having surgery to remove the cancer?
Have you had scans to check the cancer's spread?
Is this your first time having surgery for this cancer (not a returning cancer)?
Are you able to understand and agree to take part in the study?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement will be quite straightforward. You will receive the standard medical care you would normally have for your bowel cancer. The main difference is that your medical images (like MRI scans) taken before your surgery will be carefully reviewed by radiologists to look for tiny cancer deposits. This information will then be shared with the pathologists who examine the tissue removed during your surgery. This extra step helps compare what the scans show with what the lab tests find.

You won't need to have any extra hospital visits or take any new medications because of the study. After your surgery, doctors will continue to check on your health as they normally would. This follow-up will continue for five years, but it will be part of your routine care, not extra appointments just for the study. The total duration of your active involvement with the study's specific procedures (the mapping) would be around the time of your surgery, but the data collection and follow-up continues for five years as part of your standard care.

Potential risks and benefits

Taking part in this study does not involve any direct treatments or tests that are different from your usual care, so there are no additional physical risks or side effects from the study itself. Any information gathered will help the research team understand more about bowel cancer. The main potential benefit is that the study might lead to more accurate diagnosis of these tiny cancer deposits in the future, which could help guide treatment decisions for other patients and improve their understanding of their condition. While you might not directly benefit from the new mapping technique, you are contributing to important medical knowledge. You are free to withdraw from the study at any time 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 Marsden Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are 'extranodal tumour deposits'?

These are very small clusters of cancer cells that are found outside the main tumour, often in the surrounding fatty tissue.

Will I have different treatment if I join this study?

No, you will receive the same standard treatment and care that you would normally have for your cancer, regardless of whether you join the study.

Do I need extra scans or doctor's appointments?

No, all scans and appointments will be part of your usual medical care, not extra visits specifically for the study.

How long will I be involved in the study?

The information from your scans and surgery will be used, and your follow-up will be tracked for five years as part of your routine care.

Why is this study important?

It aims to improve how accurately we find tiny cancer spots, which could help doctors better understand the cancer and plan treatments for future patients.

How to find out more

Caroline Martin

c.martin1@imperial.ac.uk +44 (0) 7749 655 817 Official trial record

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