RecruitingOBSERVATIONAL

CfDNA in Hereditary And High-risk Malignancies 2

This study is testing a new blood test designed to find cancer early in people who have a higher chance of developing it due to their genes. These are often called hereditary cancer syndromes. The main goal is to see how well this new blood test works compared to the usual check-ups. Researchers want to know if it can find cancers sooner, which could lead to better treatment outcomes and might even extend lives. They will also be asking patients about their experiences, feelings, and thoughts on having this new test and its results. This research could lead to simpler and more effective ways of checking for cancer in those at higher risk.

At a glance

Status

Recruiting

Sponsor

University Health Network, Toronto

Enrolment target

1,000

Start

19 Apr 2024

Estimated completion

01 Dec 2031

Hereditary Cancer Syndrome

What is this study about?

This study is investigating an exciting new type of blood test that could help detect cancer at a very early stage. It's specifically for people who have a higher risk of getting certain cancers because of their family history or genetic makeup. These conditions are sometimes called "hereditary cancer syndromes." If we can find cancer earlier, treatments often work better and people have a higher chance of a successful recovery.

The researchers want to compare this new blood test with the standard ways doctors currently check for cancer. They'll be looking at whether the new test can find cancers that might otherwise be missed or found later. The study will also explore how finding cancer early might change the type of treatment people receive and ultimately, whether it helps people live longer and healthier lives.

Beyond just the science, the study also cares about how people feel. Participants will be asked through questionnaires and interviews about their thoughts on the new blood test, how easy it is to have, and how they feel about getting their results. This will help doctors understand if the test is not only effective but also comfortable and helpful for patients in their daily lives.

Key takeaways

Tests a new blood test for early cancer detection.
Aims to help people at high risk for hereditary cancers.
Compares new test against standard cancer screenings.
Will collect blood samples about three times a year if you're in the test group.
Investigates patient experiences and feelings about the new test.
Participation could lead to better cancer screening for future generations.

Who may be eligible?

You might be able to join this study if you have a family history or a specific genetic change that puts you at a higher risk for certain cancers, like some types of breast, ovarian, or stomach cancer, or conditions like Lynch Syndrome. Even if your genetic test results weren't clear, but your family history strongly suggests one of these conditions, you might still be eligible.

It's important that you are already having regular check-ups with your doctor for cancer screening, as part of your usual care. Before joining, you will need to read and sign a consent form, which explains all the details of the study fully.

You cannot join if you've had cancer diagnosed and treated less than three years ago, or if you were diagnosed more than three years ago but haven't received treatment. Also, if doctors are currently investigating you because they suspect you might have cancer, you won't be able to take part. Finally, you need to be able to commit to the study's requirements, which includes giving blood samples regularly if you're placed in the group testing the new blood test.

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.

Do you have a confirmed genetic condition that increases your cancer risk, OR a strong family history of such a condition?
Are you currently having regular cancer check-ups from your doctor?
Have you NOT been treated for cancer in the last 3 years?
Are you NOT currently being investigated for suspected cancer?
Are you able to provide blood samples regularly (about 3 times a year) if requested?

Answer every question to see your result.

What does participation involve?

If you join this study, your involvement could last for some time, as it's designed to track health over a period. Participants will be divided into two main groups. One group will continue with their usual cancer check-ups, as recommended by their doctor. The other group will also have their usual check-ups, but they will additionally receive the new experimental blood test.

If you are in the group getting the new blood test, you can expect to provide blood samples about three times a year. These samples will be used to look for very early signs of cancer. The study doesn't involve new medications; it focuses purely on a diagnostic blood test. The overall duration of your participation will be discussed in detail before you decide to join, and it's designed to see how effective the test is over time. You will not have to pay for any tests related to the study.

Potential risks and benefits

Potential benefits of taking part include the possibility of having cancer detected earlier than with standard methods, which could lead to more successful treatment. Your participation also helps researchers learn more about new ways to screen for cancer, which could help many others in the future. However, there's always a chance that the new test might not find cancer, or could give a false alarm leading to unneeded worry or further tests. As with any medical study, there's also the minor risk associated with giving blood samples. It's important to remember that you are free to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (8)

BC Cancer Agency
Verified postcode
Vancouver, Canada· Not yet recruiting
Eastern Health
Verified postcode
St. John's, Canada· Not yet recruiting
IWK Health Centre
Verified postcode
Halifax, Canada· Not yet recruiting
The Hospital for Sick Children
Verified postcode
Toronto, Canada· Not yet recruiting
Sinai Health System
Verified postcode
Toronto, Canada· Recruiting
University Health Network
Verified postcode
Toronto, Canada· Recruiting
Women's College Hospital
Verified postcode
Toronto, Canada· Not yet recruiting
Jewish General Hospital
Verified postcode
Montreal, Canada· Not yet recruiting

Common questions

What is a 'hereditary cancer syndrome'?

It means you have a higher chance of getting certain cancers because of genes you inherited from your family.

What is 'cell-free DNA analysis'?

It's a new type of blood test that looks for tiny pieces of DNA in your blood that might come from a very early cancer.

Will this study change my regular cancer check-ups?

No, you will continue with all your usual cancer screenings as advised by your doctor. The new blood test is an addition, not a replacement.

What if the new blood test finds something unusual?

If the test suggests something needs further investigation, your study doctor will discuss this with you and your regular care team.

How long will I be in the study?

The study involves long-term observation to track health outcomes. The exact duration will be explained to you before you consent to participate.

How to find out more

Julia Sobotka, MSc

charm@uhn.ca 416-409-1387 Official trial record

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