RecruitingNAINTERVENTIONAL

Impact of Using the Oncogramme® Device to Select the First Line of Treatment for Patients With Metastatic Colorectal Cancer

This study investigates using a special test called Oncogramme® for people with advanced bowel cancer that has spread (metastatic colorectal cancer). Bowel cancer is a common and serious illness, and finding the right treatment is crucial. Currently, doctors choose treatments based on general guidelines, but this new test aims to make treatment more personal. The Oncogramme® test checks how a patient's own cancer cells react to different medicines in a lab. The study wants to see if using these test results helps doctors select treatments that are more effective for individual patients, lead to fewer side effects, and ultimately improve how long people live and their overall well-being. It compares patients whose doctors use the test results with those whose doctors don't.

At a glance

Status

Recruiting

Phase

Sponsor

Oncomedics

Enrolment target

450

Start

07 Jun 2023

Estimated completion

01 Dec 2028

Metastatic Colorectal Cancer

What is this study about?

Bowel cancer, also known as colorectal cancer, is a common type of cancer in the UK. When this cancer spreads to other parts of the body, it's called metastatic colorectal cancer, and it can be very serious. Treatments usually involve surgery and various medications like chemotherapy and targeted therapies, sometimes used together.

Currently, doctors choose the first line of treatment based on national guidelines and discussions with a team of experts. While these choices consider what's worked for many people and the possible side effects, it's hard to know which treatment will be most effective for each individual patient. This is why researchers are looking for ways to make treatment more personal.

This study focuses on a new tool called Oncogramme®. This is a special lab test where a small part of a patient's cancer cells are taken and tested to see how they react to different cancer drugs. The idea is that this test could help doctors see which specific medications or combinations of treatments might work best for that patient's unique cancer. The study hopes that by using this test, doctors can pick treatments that are more likely to shrink the cancer, have fewer side effects, and improve a patient's life and survival.

Key takeaways

This study evaluates a personalised cancer treatment approach.
It aims to find the best first treatment for advanced bowel cancer.
The Oncogramme® test uses your own cancer cells to guide treatment.
Participation involves being randomly assigned to a treatment decision group.
The goal is better treatment effectiveness and fewer side effects.
You can withdraw from the study at any time.

Who may be eligible?

To be considered for this study, you need to be at least 18 years old and have bowel cancer that has spread (metastatic colorectal cancer). Your cancer must be confirmed by a lab test. You should also be well enough to receive standard chemotherapy treatments.

There are also some specific health requirements, like good blood counts and kidney/liver function. You shouldn't have recently had a heart attack, serious heart problems, or an uncontrolled high blood pressure. Also, you must not have received chemotherapy for your metastatic cancer before, although some previous chemotherapy that ended more than 6 months ago might be allowed.

Important conditions that would stop you from joining include if your cancer could be completely cured with surgery, or if you have certain serious heart or stomach issues. You also need to be able to give your informed consent, meaning you 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 18 years or older?
Do you have bowel cancer that has spread?
Are you generally well enough for chemotherapy?
Have you not had chemotherapy for your metastatic cancer yet (unless it was a long time ago)?
Are your blood tests (like blood counts, liver, kidney function) within healthy ranges?
Do you have good heart health and controlled blood pressure?

Answer every question to see your result.

What does participation involve?

If you join this study, you will be assigned to one of two groups by chance. This is like flipping a coin to decide, and neither you nor your doctor will get to choose which group you are in. In one group, your medical team will receive the results from the Oncogramme® test to help them decide on your treatment. In the other group, they will not see these results, and your treatment will be chosen in the usual way, based on standard guidelines. All other aspects of your care will be the same.

Throughout the study, you will have regular medical appointments, assessments, and tests, just as you would normally for your cancer treatment. There won't be any new or different medications specifically for the study itself, as it's about how treatment decisions are made. The total duration of your participation will depend on your treatment plan and follow-up, but generally, studies like this involve ongoing monitoring of your health and cancer status.

Potential risks and benefits

Taking part in this study could potentially lead to your doctor choosing a treatment that is more effective for your specific cancer, possibly reducing side effects and improving your overall outlook. However, there's no guarantee the Oncogramme® test will improve your treatment, and it's a research study, so the benefits are not certain. All treatments carry potential side effects, and these will be discussed with you by your medical team. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Hôpital Saint Joseph Marseille
Verified postcode
Marseille, France· Recruiting

Common questions

What is metastatic colorectal cancer?

This is bowel cancer that has spread from where it started to other parts of your body.

What is the Oncogramme® test?

It's a lab test where your own cancer cells are checked to see how they react to different cancer medicines.

Will I definitely get a better treatment if I join?

This is a research study to find out if the test helps. We hope it will, but there's no guarantee.

Will treatment be different if I'm in the study?

Only how your doctor decides on treatment might be different, either using the test results or standard methods. The treatments themselves are standard.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, and it won't affect your medical care.

How to find out more

Christophe Lautrette, PhD

c.lautrette@oncomedics.com 0033 5 55 33 85 25 Official trial record

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