RecruitingOBSERVATIONAL

Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion

This study aims to understand how bowel cancer spreads. We are looking at something in the blood called 'circulating tumour DNA' (ctDNA) in patients undergoing surgery for bowel cancer. Specifically, we want to see if changes in this ctDNA are linked to whether the cancer shows signs of growing into blood vessels around the bowel, a feature called "extramural venous invasion" (EMVI), which doctors look for on scans. Taking part involves giving a couple of extra blood samples around the time of your surgery. You will then have follow-up appointments for up to three years, just like you would normally. This study doesn't involve any new treatments or medicines; it's purely observational, meaning we're just collecting information to learn more.

At a glance

Status

Recruiting

Sponsor

Imperial College London

Enrolment target

100

Start

01 Nov 2015

Estimated completion

01 Dec 2029

Cancer Rectal Cancer

What is this study about?

This study, called "Circulating Tumour DNA (ctDNA) in Patients With Colorectal Cancer and the Relationship to Imaging Features of Extramural Venous Invasion," is designed to help us better understand how bowel cancer can spread throughout the body. We believe that often, cancer cells can travel through the bloodstream. While doctors can sometimes see signs of this on scans, we are looking for a more detailed way using blood tests.

We're focusing on something called "circulating tumour DNA" (ctDNA). This is tiny bits of genetic material that cancer cells release into your bloodstream. By looking at these tiny bits, we hope to find out if there's a connection between what we see on your scans (specifically, if the cancer looks like it's growing into nearby blood vessels, known as "extramural venous invasion" or "EMVI") and what we find in your blood.

Understanding this link is crucial. If we can confirm that ctDNA is a reliable sign of cancer potentially spreading through blood vessels, it could lead to new ways of predicting how a person's cancer might behave and help doctors make better decisions about the best treatment plan for you in the future. This study is purely for research and won't change your current treatment, but it will help us improve care for others.

Key takeaways

This study helps understand how bowel cancer spreads.
It involves giving two extra blood samples around your surgery time.
No new treatments or medications are given.
Your regular follow-up will continue for up to three years.
Your participation helps improve future bowel cancer care.
You can stop participating at any time without affecting your medical care.

Who may be eligible?

To be considered for this study, you must have bowel cancer (medically known as colorectal adenocarcinoma) that has been confirmed by a biopsy. Your treatment plan must include surgery to remove the cancer, with the aim of curing it.

It's important that scans you've had recently (within six weeks before your surgery) show that your cancer has not spread to other parts of your body. Also, you need to be at least 16 years old to participate. Before you can join, you'll need to read and sign a consent form, showing you understand what's involved and agree to take part.

However, you wouldn't be able to join if your cancer has already spread to other organs (even if those spots could be surgically removed), or if you have another separate cancer at the same time. Also, if you can't have certain scans that doctors use to check for cancer growing into blood vessels, you wouldn't be eligible.

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.

I have bowel cancer confirmed by a biopsy.
I am planned for surgery to cure my cancer.
My recent scans show the cancer hasn't spread to other parts of my body.
I am aged 16 or over.
I haven't had another cancer at the same time.

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, your participation is quite straightforward and won't change your planned surgery or treatment.

* **Blood Samples:** You'll have two extra blood samples taken. The first will be before your surgery. The second will be taken either during your surgery or within 24 hours afterwards. Each sample will be about 20ml, which is roughly two standard blood test tubes. * **Follow-up:** After your surgery, you will continue with your usual check-ups. The study team will then follow your progress annually for up to three years. This means they will keep track of your health updates, but you won't need to attend extra study-specific appointments during this follow-up period.

There are no special medications or additional assessments required specifically for this study. The total duration of active participation (blood samples) is very short, centered around your surgery, with data collection continuing for three years.

Potential risks and benefits

Taking part in this study generally carries very low risks. The main addition to your care is giving two extra blood samples, which might cause minor discomfort, bruising, or, in rare cases, a small infection at the injection site, just like any blood test. There are no direct personal benefits to you from participating, as this study is purely observational and won't change your treatment. However, the information gathered will be incredibly valuable to researchers, potentially helping to improve our understanding of bowel cancer and leading to better care for future patients. Remember, your participation is entirely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (3)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Queen Elizabeth the Queen Mother Hospital
Verified postcode
Margate, United Kingdom· Recruiting
St Mary's Hospital (Imperial)
Verified postcode
Hammersmith, United Kingdom· Recruiting
Royal Marsden Hospital NHS Foundation Trust
Verified postcode
Sutton, United Kingdom· Recruiting

Common questions

What is 'ctDNA'?

CtDNA stands for 'circulating tumour DNA'. It's tiny bits of genetic material released by cancer cells into your bloodstream. We're looking at it to understand more about your cancer.

Will taking part change my cancer treatment?

No, this study is purely for research. It will not change the standard treatment you receive for your bowel cancer.

Do I need to come for extra hospital visits?

You won't need any special extra visits for the study. The blood samples will be taken around the time of your surgery, and your follow-up will be part of your usual care.

Will I find out my ctDNA results?

The results from your ctDNA tests are for research purposes only and will not be shared with you or used for your personal treatment decisions at this time.

What if I change my mind about participating?

You are free to withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your doctors.

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.