Development of a Risk Stratification Score for Recurrent Venous Thromboembolism and Treatment-related Clinically Relevant Bleeding in Patients With Cancer-associated Thrombosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Cancer-associated Thrombosis. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Canada
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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
Primary outcome measures
- Recurrent VTE [Time frame: 6 months]
Secondary outcome measures (2)
- Overall mortality [Time frame: 6 months]
- Clinically relevant bleeding [Time frame: 6 months]
Eligibility 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Canada · 1 center
- Ottawa Hospital Research Institute — Ottawa
Identifiers
NCT: NCT06894576 · 20240308-01T