Actively Recruiting

Early Phase 1
Age: 12Years +
All Genders
NCT06736158

Early Genomic Testing for Inherited Bleeding Disorders

Led by Queen's University · Updated on 2025-07-31

212

Participants Needed

3

Research Sites

99 weeks

Total Duration

On this page

Sponsors

Q

Queen's University

Lead Sponsor

U

Unity Health Toronto

Collaborating Sponsor

AI-Summary

What this Trial Is About

The investigators aim to test the introduction of genomic testing early in the diagnostic pathway for inherited bleeding disorders in patients who have not received a diagnosis after first-line testing. The goal of this clinical trial is to test the introduction of genomic testing early in the diagnostic pathway for patients referred to Hematology for a suspected inherited bleeding disorder. The main questions it aims to answer are: 1. Does adding early genomic testing increase the number of patients who are diagnosed? 2. Does adding early genomic testing decrease the overall time to diagnosis? 3. Is it cost-effective to include early genomic testing in the diagnostic pathway? The investigators will compare with a control group of participants who are receiving standard care (no early genomic testing). Participants will randomized to a standardized diagnostic testing plus early genomic testing group or to the standardized diagnostic testing group only (with the possibility of being offered genomic testing after 1 year in the study).

CONDITIONS

Official Title

Early Genomic Testing for Inherited Bleeding Disorders

Who Can Participate

Age: 12Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • New patient referred for abnormal bleeding.
  • Hemostasis expert clinician determined abnormal bleeding history AND family history of bleeding
  • OR no family history of bleeding but hemostasis expert clinician determined severe bleeding history.
Not Eligible

You will not qualify if you...

  • Prior diagnosis of an inherited bleeding disorder.
  • Acquired cause of bleeding (i.e., medication known to cause bleeding, significant renal or hepatic disease)

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 3 locations

1

Queen's University/Kingston Health Sciences Centre

Kingston, Ontario, Canada, K7L 3N6

Actively Recruiting

2

The Ottawa Hospital

Ottawa, Ontario, Canada, K8N 1J4

Actively Recruiting

3

Unity Health

Toronto, Ontario, Canada, M5B 1W8

Not Yet Recruiting

Loading map...

Research Team

J

Julie Grabell, CCRP

CONTACT

M

Megan Chaigneau, RN

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

DIAGNOSTIC

Number of Arms

2

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here