Active not recruitingNAINTERVENTIONAL

Incidental Genomics

This study explores how people with cancer feel about getting results from advanced genetic tests called genomic sequencing (GS). Sometimes, these tests find unexpected health information, not just about the cancer being investigated. We want to understand if receiving this ‘extra’ information causes stress, helps people make healthy changes, or is useful in other ways. We're comparing people who get only cancer-related genetic results with those who also receive these unexpected findings. We’ll look at people's feelings, how useful the results are for their health, and the costs involved. This will help doctors understand the best way to use these new tests in the future.

At a glance

Status

Active not recruiting

Phase

Sponsor

Unity Health Toronto

Enrolment target

289

Start

25 Jul 2018

Estimated completion

01 Oct 2027

Cancer

What is this study about?

Doctors are increasingly using a modern genetic test called genomic sequencing (GS) to understand illnesses like cancer better and help choose the best treatments. This test looks deeply into your genes, your body's instruction manual. While it's great for targeting specific conditions, it can sometimes reveal other important health information you weren't expecting. This extra information might be about risks for other diseases now or in the future, even if they're not related to your main condition.

Because GS is a relatively new tool, we have many questions about how best to use it. For example, how do people feel when they get these unexpected results? Do they become more worried or does it help them make healthier choices? Is this extra information actually useful for your health, and what are the costs involved for you and the health service? This study aims to find answers to these important questions.

Key takeaways

This study explores how people feel about advanced genetic test results.
It compares receiving only cancer results versus cancer results plus unexpected findings.
The goal is to understand emotional impact, health usefulness, and costs.
This will help guide future use of genetic testing in healthcare.
Participants are adult cancer patients who've had previous unclear genetic tests.

Who may be eligible?

This study is for adult cancer patients. To take part, you must: have had a previous genetic test for cancer that didn't find a clear answer (it was negative or unclear), be 18 years old or older, and be able to speak and read English.

However, you cannot join if you have very advanced cancer (stage 4) or are currently having treatment like chemotherapy, radiotherapy, or scheduled surgery (though people on hormonal therapy, like tamoxifen, can take part). You're also not eligible if you've already had a specific genetic mutation for cancer found, if you haven't had an initial gene test for your cancer, or if you've already had genomic sequencing before. People who are currently pregnant or whose partner is pregnant cannot join at the start of the study.

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.

I am an adult (18 or older).
I have been diagnosed with cancer.
I can speak and read English.
I have had a previous genetic test for cancer that came back negative or unclear.
I am not currently undergoing active cancer treatment like chemo or radiation (hormone therapy is okay).
I do not have very advanced, stage 4 cancer.

Answer every question to see your result.

What does participation involve?

If you join this study, you will be part of a group of adult cancer patients. Your participation involves receiving genomic sequencing. Depending on which group you are assigned to, you will either receive only the genetic results directly related to your cancer, or you will also receive any additional, unexpected health information that the genetic test reveals. We will be checking in with you to understand your feelings and health decisions over time.

This will involve filling out surveys to help us understand your distress levels and any changes in your health habits. We may also look at your health records to see how you use healthcare services. Some participants may also be asked to do in-depth interviews to share their personal experiences with the genetic results. The total length of your involvement in the study will be clarified by the study team.

Potential risks and benefits

Participating in this study might help us learn more about how to best use genetic testing for all patients in the future. You might also gain valuable health information that could help you make informed decisions about your health. However, some people might find receiving unexpected health information to be worrying or stressful. It's important to remember that all participants have the right to withdraw from the study at any time without giving a reason, and this will not affect your future medical care.

Locations (3)

Mount Sinai Hospital
Verified postcode
Toronto, Canada
Princess Margret Cancer Centre
Verified postcode
Toronto, Canada
Sunnybrook Hospital
Verified postcode
Toronto, Canada

Common questions

What is genomic sequencing (GS)?

Genomic sequencing is an advanced genetic test that looks at your genes in great detail. It can help doctors understand your illness better and choose tailored treatments.

What are 'incidental results'?

Incidental results are unexpected health findings from a genetic test. They are not directly related to the main reason you had the test, but they might be important for your health.

Will I get all my genetic results?

Some participants will get only the results related to their cancer. Others will also receive any unexpected, additional health information found during the genetic test.

Is this study only for people with cancer?

Yes, this study is specifically for adult patients who have been diagnosed with cancer.

Will I have to pay to be in the study?

We will be looking at the costs involved with these tests, including any personal costs you might have. The study team will provide more details on this.