NCT06736158 Early Genomic Testing for Inherited Bleeding Disorders
| NCT ID | NCT06736158 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | Queen's University |
| Condition | Bleeding Disorder |
| Study Type | INTERVENTIONAL |
| Enrollment | 212 participants |
| Start Date | 2025-05-31 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 212 participants in total. It began in 2025-05-31 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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).
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * Prior diagnosis of an inherited bleeding disorder. * Acquired cause of bleeding (i.e., medication known to cause bleeding, significant renal or hepatic disease)
Contact & Investigator
Paula D James, MD, FRCPC
PRINCIPAL INVESTIGATOR
Queen's University
Frequently Asked Questions
Who can join the NCT06736158 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, studying Bleeding Disorder. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06736158 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06736158 currently recruiting?
Yes, NCT06736158 is actively recruiting participants. Contact the research team at grabell@queensu.ca for enrollment information.
Where is the NCT06736158 trial being conducted?
This trial is being conducted at Kingston, Canada, Ottawa, Canada, Toronto, Canada.
Who is sponsoring the NCT06736158 clinical trial?
NCT06736158 is sponsored by Queen's University. The principal investigator is Paula D James, MD, FRCPC at Queen's University. The trial plans to enroll 212 participants.