Recruiting

Risk Stratification Score

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT06894576

Conditions

Cancer-associated Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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

Study ID

NCT06894576

Start date

Dec 3, 2024

Status verified date

Mar, 2025

Completion date

Dec, 2027

Anticipated

Primary completion date

Dec, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Recurrent VTE [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Kristina Vrotniakaite-Bajerciene, MD

613-737-8899kvrotniakaite@toh.ca

Locations

Ottawa Hospital Research Institute

Recruiting

Ottawa, Ontario, Canada, K1H8L6

Contacts

Heather Langlois

hlanglois@ohri.ca

Principal Investigator:

Marc Carrier, MD

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Mar 25, 2025

Last verified

Mar, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2025-03-25.