Genetic Testing for Bleeding Disorders
(GT4BD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether early genetic testing can diagnose individuals with suspected inherited bleeding disorders more quickly and accurately. Researchers aim to determine if this approach results in faster diagnoses and proves cost-effective compared to standard testing methods. Participants will either receive early genetic testing alongside standard tests or follow the standard testing path, which may include genetic testing after a year. Ideal candidates are new patients with unusual bleeding patterns and either a family history of bleeding or a severe personal bleeding history. As an Early Phase 1 trial, this research focuses on understanding the role of early genetic testing in diagnosing bleeding disorders, offering participants a chance to contribute to groundbreaking medical advancements.
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 prior data suggests that this genomic testing is safe for diagnosing inherited bleeding disorders?
Research has shown that genetic testing for inherited bleeding disorders is generally safe and well-tolerated. This testing examines genes to identify changes that might explain a bleeding problem. So far, no serious side effects from the testing itself have been reported.
The main goal is to obtain accurate results and interpret them correctly, aiding doctors in making better treatment decisions. Although genetic testing is new in some areas, it has been safely used in others, helping to identify conditions early and plan care. Participation in this trial involves testing considered safe based on current knowledge.12345Why are researchers excited about this trial?
Researchers are excited about the genetic testing for bleeding disorders trial because it has the potential to revolutionize how these conditions are diagnosed. Unlike the standard diagnostic methods, which often involve a series of blood tests and medical history evaluations, early genomic testing can quickly identify specific genetic mutations responsible for bleeding disorders. This faster and more precise approach could lead to earlier interventions and personalized treatment plans, ultimately improving patient outcomes. By incorporating genomic testing into the diagnostic pathway, there's a hope to reduce the time and uncertainty patients often face when trying to understand their condition.
What evidence suggests that early genomic testing is effective for diagnosing inherited bleeding disorders?
Research has shown that early genetic testing in the diagnosis process can better identify inherited bleeding disorders. In this trial, participants in the "Early Genomic Testing Diagnostic Pathway" arm will receive early genomic testing alongside standard diagnostic testing. Traditional tests diagnose only about 30% of these cases and often overlook less common disorders. Genetic testing provides more accurate diagnoses, particularly for patients with unusual symptoms. This method not only increases the number of correct diagnoses but also accelerates the process. Therefore, early genetic testing is considered a promising tool for faster and more accurate diagnosis of bleeding disorders.16789
Who Is on the Research Team?
Paula D James, MD, FRCPC
Principal Investigator
Queen's University
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
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