Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

DPDIMP#1-trial: Impact of DPYD gene test on the safety and efficacy of fluoropyrimidine therapy

This research is about improving treatment for people with breast cancer or colon cancer. Many cancer medicines, like fluorouracil, capecitabine, and tegafur, are very effective but can sometimes cause side effects. This study aims to find out if checking a specific gene, called DPYD, before treatment can help doctors choose the safest and most effective dose of these medicines for each patient. We're looking at how different versions of these drugs work in the body, including how they are absorbed and used. The goal is to make these important cancer treatments safer and more personalised, reducing side effects while ensuring they work as well as possible.

At a glance

Status

Ongoing, recruiting

Phase

Phase III and phase IV (Integrated)

Sponsor

HUS-Yhtymae

Enrolment target

1,000

Start

29 Oct 2024

Breast cancer Colon cancer

What is this study about?

This study is particularly interested in a type of cancer medicine called fluoropyrimidines, which includes drugs like fluorouracil, capecitabine, and tegafur. These are commonly used to treat cancers like breast cancer and colon cancer. While very effective, these medicines can sometimes cause strong side effects. Researchers believe that some people react differently to these drugs because of their genes – specifically, a gene called DPYD.

Your body uses the DPYD gene to make an enzyme that breaks down these cancer medicines. If your DPYD gene isn't working as it should, the medicine might stay in your body for too long or build up to higher levels, which can lead to more severe side effects. This study wants to see if checking a patient's DPYD gene before they start treatment can help doctors give them the right amount of medicine from the start, making treatment both safer and more effective.

To do this, the study will look at how different forms of these medicines (like Teysuno, Capecitabine Orion, and Fluorouracil Accord) move through the body over time. They will be taking samples of blood to measure the levels of the medicines and their breakdown products. By understanding this better, doctors hope to offer more personalised treatment plans, reducing the risk of side effects while ensuring the medicine works best to fight the cancer.

Key takeaways

This study aims to make cancer treatments safer and more effective.
It focuses on breast and colon cancer common medicines.
Researchers are exploring if a gene test (DPYD) can help personalise drug doses.
Participation involves receiving standard treatments with extra monitoring.
The goal is to reduce side effects and improve treatment outcomes for patients.

Who may be eligible?

To join this study, people need to be at least 18 years old – there's no upper age limit. Both men and women can take part.

More detailed checks will happen if you express an interest. These will include looking at your specific type of breast or colon cancer and your overall health. Your doctor will discuss all the specific requirements with you to make sure this study is right for your situation.

Quick self-check

Are you 18 years old or older?
Do you have a diagnosis of breast cancer or colon cancer?
Are you able to agree to take part in the study?
Are you willing to have blood samples taken during treatment?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would be receiving one of the study medicines for your breast or colon cancer, as prescribed by your doctor. The study would involve giving blood samples, potentially from your fingertip or an arm, at different times. These samples will help researchers understand how the medicine is processed by your body. The total duration of your participation would depend on your treatment plan; the researchers will explain how long you would be involved, including follow-up appointments.

Potential risks and benefits

While we cannot promise direct benefits to you, information gained from this study could help improve treatment for future cancer patients. Taking part means receiving established cancer treatments, with extra monitoring to understand how they work in your body. There's always a small risk associated with blood tests, such as bruising or discomfort. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Finland

Common questions

What is DPYD and why is it important?

DPYD is a gene that helps your body process certain cancer medicines. If it doesn't work correctly, the medicine might build up and cause more side effects.

What kind of cancers is this study for?

This study is for people who have been diagnosed with breast cancer or colon cancer.

What are 'fluoropyrimidine therapy' medicines?

These are common cancer medicines like fluorouracil, capecitabine, and tegafur, used to treat various cancers.

Will I have to take a new medicine if I join?

You will receive one of the study medicines which are already approved treatments for breast or colon cancer, but the study will monitor how your body handles them.

Can anyone over 18 join?

Yes, adults aged 18 and older can potentially join, but there will be other health checks to make sure the study is suitable for you.