Developing a risk score for blood clots in cancer patients
Development of a Risk Stratification Score for Recurrent Venous Thromboembolism and Treatment-related Clinically Relevant Bleeding in Patients With Cancer-associated Thrombosis
This study is trying to create a tool to help doctors figure out which cancer patients are at higher or lower risk for blood clots and bleeding after their diagnosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Ottawa Hospital Research Institute Academic / other |
| Locations | 1 site (Ottawa, Ontario) |
| Trial ID | NCT06894576 on ClinicalTrials.gov |
What this trial studies
This observational study aims to create a risk assessment model that identifies cancer-associated thrombosis patients who are at low and high risk for recurrent venous thromboembolism and clinically relevant bleeding within six months of diagnosis. It will involve the collection of blood samples for a biobank to support future research in cancer genetics and hemostasis. Participants will be followed up at three and six months post-enrollment to monitor for any bleeding events and changes in treatment. The study is expected to recruit participants over a two-year period.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with documented cancer-associated thrombosis who are receiving anticoagulant treatment.
Not a fit: Patients with unusual sites of thrombosis or those under 18 years old may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and management of blood clots in cancer patients, potentially reducing complications and enhancing patient outcomes.
How similar studies have performed: Other studies have explored risk assessment in thrombosis, but this specific approach to cancer-associated thrombosis is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Objectively documented distal and/or proximal DVT of the limb (upper or lower extremity) and/or PE, splanchnic vein thrombosis and/or cerebral sinus vein thrombosis in presence of active cancer of all types * Intended treatment of CAT for at least 6 months with parenteral or oral anticoagulants at therapeutic dosing. * Estimated life expectancy \> 6 months * Willingness to give an informed consent * Age ≥ 18 years Exclusion Criteria: * Unusual site CAT (gonadal vein thrombosis, ovarian vein thrombosis, retinal vein thrombosis) * Superficial vein thrombosis * Refusal of informed consent \> 72 hrs of anticoagulants * Age \< 18 years old
Where this trial is running
Ottawa, Ontario
- Ottawa Hospital Research Institute — Ottawa, Ontario, Canada (Recruiting)
Study contacts
- Principal investigator: Marc Carrier, MD — Ottawa Hospital
- Study coordinator: Kristina Vrotniakaite-Bajerciene, MD
- Email: kvrotniakaite@toh.ca
- Phone: 613-737-8899
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.