RecruitingOBSERVATIONAL

Tracking Mutations in Cell Free Tumour DNA to Predict Relapse in Early Colorectal Cancer

This research, called TRACC, is split into two parts. Part B studies whether special blood tests can detect tiny amounts of cancer cells (called 'cell-free tumour DNA' or ctDNA) after surgery for bowel cancer. The aim is to see if finding these cells earlier can predict if the cancer might return. Part C then uses these blood test results to decide if patients with higher risk bowel cancer truly need chemotherapy after surgery. The goal is to find out if using this blood test as a guide can help some patients avoid chemotherapy and its side effects, without making their cancer more likely to come back. This could mean more personalised and gentle treatment.

At a glance

Status

Recruiting

Sponsor

Royal Marsden NHS Foundation Trust

Enrolment target

1,000

Start

05 Dec 2016

Estimated completion

31 Jul 2031

Colorectal Cancer

What is this study about?

When people have surgery for bowel cancer, doctors always want to make sure all the cancer cells are gone. Sometimes, tiny cancer cells can remain, even if they can't be seen on scans. If these cells are not treated, the cancer might come back later. This study is designed to explore a new way to find these hidden cells much earlier than current methods.

This research is called TRACC and has two main parts. In Part B, if you join, doctors will collect blood samples over time after your surgery. They will look for tiny bits of cancer DNA, called ctDNA, in these blood samples. The exciting idea is that by finding this ctDNA, they might be able to tell much earlier if someone is at risk of their cancer returning. This could potentially lead to quicker decisions about further treatment.

In Part C, the study takes this a step further. If you have a higher-risk bowel cancer, after your surgery, doctors will use the results of the ctDNA blood test to help decide whether you should have chemotherapy. Some patients with higher risk may be recommended chemotherapy, but it can have side effects. This study aims to see if using the ctDNA test can safely identify patients who might not need chemotherapy, helping them avoid its side effects, while still making sure the treatment works just as well. The ultimate goal is to offer more personalised and effective care for bowel cancer patients.

Key takeaways

Aims to predict bowel cancer return earlier using blood tests.
Explores if blood tests can guide chemotherapy decisions safely.
Could help some patients avoid unnecessary chemotherapy.
Compares new approaches with current standard treatments.
Focuses on personalised and gentler treatment options.

Who may be eligible?

You might be able to take part in this study if you are 18 years or older and have recently been diagnosed with bowel cancer that needs surgery. This applies to patients with earlier stages (Stage I, II, or III) of bowel cancer that hasn't spread to other parts of the body.

For Part B, you would be eligible if you are having surgery with the goal of completely removing the cancer.

For Part C, you would be eligible if you have a higher-risk Stage II or Stage III bowel cancer that has been fully removed by surgery. This part of the study is for patients who would usually be considered for chemotherapy after their operation.

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 18 years old or older?
Have you recently been diagnosed with Stage I, II, or III bowel cancer?
Are you having surgery to remove your bowel cancer?
Has your bowel cancer not spread to other parts of your body?
Do you understand what taking part in a study involves?

Answer every question to see your result.

What does participation involve?

If you join Part B of this study, you will have blood samples taken at various times after your surgery. These samples will be analysed to look for specific cancer markers. This involves a series of appointments for blood tests and doctors will also collect information about your health over time.

If you join Part C, after your surgery and a specific blood test, your treatment plan for chemotherapy will be decided based on the result of that blood test. You might either receive chemotherapy as guided by the blood test or receive the standard chemotherapy treatment. Your health will be closely monitored, and you will have follow-up appointments, similar to what you would usually have after bowel cancer treatment. The exact duration of your participation will depend on which part of the study you are in and your individual treatment path.

Potential risks and benefits

A potential benefit of joining this study is that it might offer a more tailored approach to your treatment, potentially allowing some patients to avoid unnecessary chemotherapy and its side effects, without compromising their care. This research could also lead to earlier detection of cancer recurrence, improving future treatments. However, there's always a possibility that the new approach might not be as effective as standard treatment, although the study is designed to minimise this risk. As with any study, there might be discomfort from blood draws or unexpected side effects from treatments. You have the right to withdraw from the study at any time without affecting your ongoing medical care.

Locations (71)

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

Milton Keynes General Hospital
Verified postcode
Milton Keynes, United Kingdom· Recruiting
Croydon University Hospital
Verified postcode
Thornton Heath, United Kingdom· Recruiting
Dorset County Hospital NHS Foundation Trust
Verified postcode
Dorchester, United Kingdom· Recruiting
Poole Hospital
Verified postcode
Poole, United Kingdom· Recruiting
Broomfield Hospital
Verified postcode
Chelmsford, United Kingdom· Recruiting
Christie NHS Foundation Trust
Verified postcode
Manchester, United Kingdom· Recruiting
Queen Alexandra Hospital
Verified postcode
Portsmouth, United Kingdom· Recruiting
University Hospital of South Manchester & Manchester Royal Infirmary
Verified postcode
Wythenshawe, United Kingdom· Recruiting
Musgrove Park Hospital
Verified postcode
Taunton, United Kingdom· Recruiting
Weston General Hospital
Verified postcode
Weston-super-Mare, United Kingdom· Recruiting
Epsom and St Helier's Hospitals NHS Trust
Verified postcode
Carshalton, United Kingdom· Active not recruiting
The Royal Marsden 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 from cancer cells that can be found in your blood. Doctors hope finding it can help track cancer.

Why is this study important?

It's important because it could lead to better ways of predicting if bowel cancer might come back and help doctors decide who really needs chemotherapy after surgery, potentially reducing strong treatments for some.

Will I still get suitable treatment for my cancer?

Yes, all treatments in this study are carefully planned and monitored by doctors. The specific part of the study aims to see if a slightly different approach works just as well as current standard care.

What if I change my mind about participating?

You can withdraw from the study at any time, for any reason. Your decision will not affect the medical care you receive from your doctors.

Will I have more doctor visits than usual?

You might have some additional blood tests and follow-up visits compared to standard care, especially for the blood sampling parts of the study. This will be fully explained before you agree to take part.

How to find out more

Hsiang-Chi Chen, MSc

traccstudy@rmh.nhs.uk 02086426011 Official trial record

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