Early Genomic Testing for Inherited Bleeding Disorders

Recruiting now · Early Phase 1

Conditions studied: Bleeding Disorder

In brief

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).

Key facts

Study ID

NCT06736158

Run by

Queen's University

People needed

212

Starts

2025-05-31

Expected to finish

2027-04-30

Last updated by the study team

2025-07-31

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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 may not qualify if…

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

Where it is running

• Queen's University/Kingston Health Sciences Centre — Kingston, Ontario, Canada (enrolling)
• The Ottawa Hospital — Ottawa, Ontario, Canada (enrolling)
• Unity Health — Toronto, Ontario, Canada

Full record on ClinicalTrials.gov

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