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

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.

Study Overview

• Status: Recruiting
• Conditions: Cancer-associated Thrombosis

Detailed Description

CAN-CATCH study is a prospective cohort study to develop a risk assessment model for VTE recurrence and clinically relevant bleeding in patients with CAT. The study is anticipated to recruit for a period of 2 years with a 3-year completion timeline.

The primary objective of this study is to prospectively develop a RAM that accurately identifies anticoagulated CAT patients at low- and high-risk of CAT recurrence and clinically relevant bleeding within 6 months following the CAT diagnosis.

The secondary objective is to create a biobank of plasma and DNA samples at the time of CAT diagnosis, linked to the annotated dataset for future translational biomarker research in cancer genetics and hemostasis.

At approved sites, participants will donate 4x4.5 mL 3.2% citrate tubes and 3x10 mL ethylenediaminetetraacetic (EDTA) tubes for blood banking.

In addition to the initial enrollment visit, participants that are enrolled will have a follow up at day 90 ± 14 days (3 months) and at day 180 ± 14 days (6 months) from randomization. Post enrollment follow-up visits will include assessment and documentation of any major and clinically relevant non-major bleeding (CRNMB), investigations for VTE, change in cancer treatment regimen, VTE risk factors, bleeding risk factors and death. Participants who experience an outcome event should continue to be followed

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Kristina Vrotniakaite-Bajerciene, MD; Phone Number: 613-737-8899; Email: kvrotniakaite@toh.ca

Study Locations

• Canada
  • Ontario
    • Ottawa, Ontario, Canada, K1H8L6
      • Recruiting
      • Ottawa Hospital Research Institute
      • Contact: Heather Langlois; Email: hlanglois@ohri.ca
      • Principal Investigator: Marc Carrier, MD
      • Sub-Investigator: Kristina Vrotniakaite-Bajerciene, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall mortality	Post-enrollment follow-up visits will include documentation of death if occuring at any time during the 6 month follow up period	6 months
Clinically relevant bleeding	Post-enrollment follow-up visits will include assessment and documentation of any major and CRNMB and bleeding risk factors at any time during the 6 month follow up period.	6 months

Collaborators and Investigators

• Sponsor: Ottawa Hospital Research Institute
• Collaborators: Canadian Institutes of Health Research (CIHR)
• Investigators: Principal Investigator: Marc Carrier, MD, Ottawa Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 3, 2024
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2027

Study Registration Dates

• First Submitted: March 18, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Embolism and Thrombosis; Thrombosis; Thromboembolism; Venous Thromboembolism
• Other Study ID Numbers: 20240308-01T

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No