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Enrolling by invitationNAINTERVENTIONAL

TRIAGE-GS: Towards Reducing Inefficiencies Affecting Genetics Encounters Through Genome Sequencing

Doctors at Canadian hospitals are studying new ways to diagnose rare genetic conditions faster in children up to 18 years old. These conditions can be hard to identify, causing delays for families seeking answers. This study, called TRIAGE-GS, investigates if performing a comprehensive gene test, called genome sequencing, as soon as a rare genetic condition is suspected, is better than the current practice. Usually, patients wait to see a genetics specialist first before getting specific tests. The research will compare these two approaches, looking at how quickly a diagnosis is made, what families and healthcare providers think, and the overall cost to the healthcare system. Taking part might involve reviewing medical records, completing questionnaires, and giving a blood sample for gene testing. The goal is to improve care and get crucial answers to families sooner.

At a glance

Status
Enrolling by invitation
Phase
NA
Sponsor
The Hospital for Sick Children
Enrolment target
200
Start
14 May 2025
Estimated completion
01 May 2028

What is this study about?

Imagine your child has health issues, and doctors suspect it might be a rare genetic condition, but they can't quite pinpoint what it is. This can be a very worrying and frustrating time for families, often involving many appointments and a long wait for answers. This study, called TRIAGE-GS, aims to find a quicker and more effective way to get those answers.

Currently, if a rare genetic condition is suspected, a child typically first sees a specialist doctor called a geneticist. After that visit, the geneticist might suggest certain genetic tests based on what they've learned. This process can take time. This study is exploring a different approach: what if a child had a full gene test, called genome sequencing, much earlier – right after a rare genetic condition is suspected, even before seeing a geneticist? Genome sequencing looks at almost all of a person's genes, potentially offering a broader search for answers.

The researchers want to see if this 'genome sequencing first' approach can lead to a diagnosis more quickly and more often than the usual care. They will also be asking families and doctors what they think about this new approach and if it makes their journey easier. Finally, they'll be looking at the costs involved to understand if this new way makes sense for the healthcare system. The ultimate goal is to help children with rare genetic conditions get a diagnosis sooner, which can open doors to better understanding, treatment, and support.

Key takeaways

  • New study exploring faster rare genetic condition diagnosis in children.
  • Compares early full gene testing with usual specialist referral.
  • Aims for quicker diagnoses and better patient experience.
  • Looks at benefits for families, doctors, and the healthcare system.
  • Participation involves medical record review, surveys, and potentially a blood test.

Who may be eligible?

This study is looking for children aged 18 years or younger who have recently been referred to a Genetics Clinic in Canada because doctors suspect they might have a rare genetic condition that hasn't been diagnosed yet. The doctors putting the study together will decide if your child's symptoms suggest that genetic testing could likely find an answer.

There are also some reasons why a child might not be able to join. For example, if they already have a clear diagnosis for a well-known genetic condition, or if they've already had extensive genetic testing like whole genome sequencing or exome sequencing. Also, if a medical geneticist has already seen your child for the same health issues in the past two years, or if they don't have health insurance, they wouldn't be able 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.

  1. Is my child 18 years old or younger?
  2. Has my child recently been referred to a Genetics Clinic for a suspected undiagnosed rare condition?
  3. Does my child NOT already have a clear diagnosis for a well-known genetic condition?
  4. Has my child NOT had extensive full genome or exome sequencing before?
  5. Has my child NOT seen a genetics specialist for the same issues in the last two years?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you and your child will be asked to do a few things. First, the study team will need to look at your child’s existing medical records to understand their health history. Throughout the study, you'll be asked to fill out up to five questionnaires. These might ask about your experiences, your child's health, and what you think about the care received. If your child is placed into the 'genome sequencing first' group, they will need to provide a blood sample for the genetic testing. The researchers want to follow participants and gather information over a period of time to see how the different approaches compare.

Potential risks and benefits

Taking part in this study might offer the benefit of potentially getting a diagnosis for your child's condition sooner, which could lead to better understanding and possibly more targeted care. However, there are also potential risks; for example, giving a blood sample can be a little uncomfortable, and learning a genetic diagnosis can sometimes bring unexpected information or uncertainty. You have the right to withdraw from the study at any time, for any reason, without it affecting your child's medical care.

Locations (2)

  • Children's Hospital of Eastern Ontario
    Verified postcode
    Ottawa, Canada
  • The Hospital for Sick Children
    Verified postcode
    Toronto, Canada

Common questions

What is 'genome sequencing'?

Genome sequencing is a very detailed genetic test that looks at almost all of your child's genes to try and find the cause of a health condition.

Will my child get a diagnosis if they join?

While the study aims to increase diagnoses, there's no guarantee your child will get a diagnosis. Some rare conditions are still very difficult to identify.

What is 'standard-of-care' in this study?

Standard-of-care is the usual way doctors currently look for genetic conditions: seeing a specialist doctor first, who then decides which specific genetic tests to order.

Does my child have to give a blood sample?

Only if your child is put into the 'genome sequencing first' group will they need to give a blood sample for the genetic test. The other group does not.

Will my child's regular care be affected if we join?

No, joining or not joining the study will not affect the usual medical care your child receives from their doctors.

How to find out more

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

Interested in taking part?

Register your interest

Share your details and the research team for "TRIAGE-GS: Towards Reducing Inefficiencies Affecting Genetic…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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