Genetic Testing for Bleeding Disorders
(GT4BD Trial)
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, if you are taking medications known to cause bleeding, you may be excluded from participating.
What data supports the effectiveness of genetic testing for inherited bleeding disorders as a treatment?
Genetic testing for inherited bleeding disorders is effective because it helps confirm diagnoses, distinguishes between similar conditions, and identifies genetic causes of bleeding, which can improve clinical care and treatment decisions. Advances in genetic testing technology, like next generation sequencing, allow for accurate identification of bleeding disorders, making it a valuable tool in diagnosing and managing these conditions.12345
Is genetic testing for bleeding disorders safe for humans?
How does genetic testing for bleeding disorders differ from other treatments?
Genetic testing for bleeding disorders is unique because it focuses on identifying the underlying genetic causes of the condition, which can lead to a more accurate diagnosis and personalized treatment plan. Unlike traditional methods that rely on clinical assessments and lab tests, genetic testing can detect specific genetic mutations and help in genetic counseling and prenatal diagnosis.12359
What is the purpose of this trial?
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).
Research Team
Paula D James, MD, FRCPC
Principal Investigator
Queen's University
Eligibility Criteria
This trial is for patients with suspected inherited bleeding disorders who haven't been diagnosed after initial tests. It's open to those referred to Hematology and requires participants not yet having a confirmed diagnosis of their condition.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Diagnostic Testing
Participants undergo standard diagnostic testing with or without early genomic testing
Follow-up
Participants are monitored for diagnostic outcomes and health-related quality of life
Economic Analysis
Economic implications and cost-effectiveness of genomic testing are analyzed
Treatment Details
Interventions
- Genetic testing for inherited bleeding disorders
Find a Clinic Near You
Who Is Running the Clinical Trial?
Queen's University
Lead Sponsor
Queen's University
Lead Sponsor
Kingston Health Sciences Centre
Lead Sponsor
The Ottawa Hospital
Collaborator
Unity Health Toronto
Collaborator