Actively Recruiting
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
Eligibility Criteria
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.
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
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
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
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