Development of a Risk Stratification Score for Recurrent Venous Thromboembolism and Treatment-related Clinically Relevant Bleeding in Patients With Cancer-associated Thrombosis

NCT06894576 | Recruiting

• 1 other identifier: 20240308-01T
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to prospectively develop a risk assessment model (RAM) that accurately identifies anticoagulated cancer-associated thrombosis (CAT) patients at low- and high-risk of recurrent venous thromboembolism (VTE) and clinically relevant bleeding within 6 months following the CAT diagnosis and to create a biobank of plasma and whole blood samples for further translational research in cancer genetics and hemostasis.

Conditions

Cancer-associated Thrombosis

Outcome Measures

Primary Outcomes (1)

• Recurrent VTE

  The primary outcome of the study will include objectively confirmed recurrent VTE (distal and/or proximal deep vein thrombosis (DVT) and/or pulmonary embolism (PE) and/or splanchnic vein thrombosis and/or cerebral venous sinus thrombosis

  6 months

Secondary Outcomes (2)

• Overall mortality

  6 months

• Clinically relevant bleeding

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients with Cancer Associated Thrombosis receiving anticoagulation treatment with a follow-up of 6 months

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Canadian Institutes of Health Research (CIHR): collaborator

Study Sites (1)

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H8L6, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

plasma from citrated whole blood, whole blood, plasma from whole EDTA blood tubes

Study Officials

• Marc Carrier, MD

  Ottawa Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kristina Vrotniakaite-Bajerciene, MD

CONTACT

613-737-8899; kvrotniakaite@toh.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 18, 2025
• First Posted: March 25, 2025
• Study Start: December 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: March 25, 2025

Record last verified: 2025-03

Locations

CA (1)