RecruitingOBSERVATIONAL

Development of a Risk Stratification Score for Recurrent Venous Thromboembolism and Treatment-related Clinically Relevant Bleeding in Patients With Cancer-associated Thrombosis

This research is looking for a better way to predict who might get another blood clot or have serious bleeding when they have cancer and are taking blood-thinning medicines. Many cancer patients develop blood clots, which are serious, and the medicines used to treat them can sometimes cause bleeding. This study wants to create a scoring system to help doctors identify high and low-risk patients more accurately within six months of their diagnosis. It also collects blood samples to help researchers understand more about cancer, genetics, and how blood clots form, potentially leading to better treatments in the future. The overall goal is to make treatment for cancer-related blood clots safer and more effective.

At a glance

Status

Recruiting

Sponsor

Ottawa Hospital Research Institute

Enrolment target

1,000

Start

03 Dec 2024

Estimated completion

01 Dec 2027

Cancer-associated Thrombosis

What is this study about?

Blood clots are a common and serious problem for people with cancer. They often need treatment with medicines called blood thinners, which prevent new clots from forming. However, these medicines can sometimes cause bleeding, which can also be dangerous. It's a tricky balance for doctors to manage. This study aims to help doctors make better decisions by developing a special scoring system.

Imagine a tool that could look at different information about a patient and predict their chances of either getting another blood clot or having a bleed while on their medication. That's what this study is trying to create. It will follow cancer patients who have had a blood clot and are taking blood thinners for six months. By carefully observing what happens to them, researchers hope to build a more accurate way to tell who is at low risk and who is at high risk of these complications.

Why does this matter? If doctors can better predict these risks, they can tailor treatments more precisely to each person. This could mean safer treatment for some and more effective treatment for others. The study also involves collecting blood samples, which will be stored in a special 'biobank'. These samples will be very valuable for future research to understand more about why cancer patients get blood clots and how genetics might play a role. This could lead to new discoveries and better ways to prevent and treat these problems in the years to come.

Key takeaways

This study helps develop a tool to predict if cancer patients on blood thinners might get another clot or have bleeding.
It involves regular check-ups over six months and blood sample collection.
Your blood samples will help future research into cancer and blood disorders.
Your current medical treatment will not change because of this study.
You can stop participating at any time without affecting your care.

Who may be eligible?

To join this study, you need to be at least 18 years old and have been diagnosed with a blood clot, such as a deep vein thrombosis (DVT) in your arm or leg, a pulmonary embolism (PE) in your lung, or a similar clot in your belly or brain. This blood clot must have happened because of your cancer. You should also be planning to take blood-thinning medication for at least six months and expect to live longer than six months.

There are some reasons why you wouldn't be able to join. For example, if your blood clot is in an unusual place like your ovaries or retina, or if it's a very superficial clot just under the skin. You also cannot be under 18 years old, and you need to be willing to give your informed consent to participate. If you've been offered blood thinners for more than 72 hours and haven't agreed to join the study yet, 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.

Are you 18 years old or older?
Have you recently been diagnosed with a blood clot due to your cancer?
Are you taking or planning to take blood-thinning medication for at least six months?
Do you expect to live longer than six months?
Are you willing to give blood samples and attend follow-up appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have an initial visit where blood samples will be taken. This will involve giving four tubes of blood (each 4.5 mL) and three larger tubes of blood (each 10 mL). These samples will be used for future research. After this first visit, you'll have two follow-up visits. The first will be around 3 months (90 days) after joining, and the second will be around 6 months (180 days) after joining. At these follow-up visits, the study team will check for any new blood clots, any bleeding (even minor, but important), any changes to your cancer treatment, and they'll ask about any other factors that might affect your risk of clots or bleeding. The total time you'd be actively involved in assessments for this study is approximately 6 months.

Potential risks and benefits

Taking part in this study could help researchers develop better ways to predict risks for cancer patients with blood clots, which might improve care for future patients. While there are no direct health benefits to you personally, your contribution is valuable for advancing medical knowledge. The main risk involves the blood draws, which can cause minor discomfort, bruising, or rarely, infection. You will continue to receive your standard medical care for your cancer and blood clots, and the study does not change your prescribed medication. You are free to withdraw from the study at any time without affecting your medical treatment.

Locations (1)

Ottawa Hospital Research Institute
Verified postcode
Ottawa, Canada· Recruiting

Common questions

What is a 'biobank'?

A biobank is like a library for biological samples, such as blood. Your samples will be stored safely for future scientific research.

Will my blood thinner treatment change if I join the study?

No, this study does not change the blood thinner medication or cancer treatment your doctor has prescribed for you.

What is a 'recurrent venous thromboembolism (VTE)'?

This is another term for a blood clot coming back or happening again.

What does 'clinically relevant bleeding' mean?

This refers to bleeding that is serious enough to need medical attention or affect your health, even if it's not life-threatening.

How long will I be followed in this study?

You will have check-ups for about six months after you join the study.

How to find out more

Kristina Vrotniakaite-Bajerciene, MD

kvrotniakaite@toh.ca 613-737-8899 Official trial record

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