Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center
About this trial
The purpose of this study is to find out whether a software tool, ctDNA/VTE (Venous Thromboembolism) risk score model, is an effective way to predict the likelihood of VTE coming back in people who have received anticoagulant treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥ 18 with a history of cancer-associated VTE (objectively confirmed symptomatic or incidental/unsuspected proximal lower-limb DVT, symptomatic pulmonary embolism [PE] or incidental PE in a segmental or more proximal pulmonary artery) and completion of between 3 and 12 months of anticoagulation with enoxaparin, dalteparin,rivaroxaban, or apixaban without current VTE-related symptoms (imaging to confirm resolution not required).
breast cancer regardless of cytotoxic-chemotherapy status
hepatobiliary cancer regardless of cytotoxic-chemotherapy status
prostate cancer regardless of cytotoxic-chemotherapy status
Disqualifiers
Contraindication to ongoing anticoagulation
Contraindication to discontinuation of anticoagulation (examples include but not limited to: known antiphospholipid syndrome or factor V leiden, active arterial thrombus, catheter-associated thrombus, on anticoagulation for atrial fibrillation or other non-oncologic reasons)
History of major bleeding in the last six months (major bleeding defined as fatal bleeding, and/or symptomatic bleeding in a critical area or organ, such as intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, or intramuscular with compartment syndrome; bleeding that necessitates acute surgical intervention; bleeding causing a fall in hemoglobin levels of 1.24 mmol/L (2 g/dL or greater) or more; or bleeding leading to a transfusion of 2 U or more of whole blood or red cells).
Known diagnosis of disseminated intravascular coagulation (DIC)
Trial design
Design model
Parallel
Treatments tested in this trial
MSK-ACCESS
Diagnostic testMSK-ACCESS is a ctDNA sequencing assay
ctDNA/VTE Risk Score:
Diagnostic testMachine learning Venous Thromboembolism/VTE risk score mode
Treatment groups
259 Participants
are divided into 2 treatment groupsGroup A: High risk for recurrent Venous Thromboembolism/VTEExperimental treatment 2 interventions
Group B: Low-risk for recurrent Venous Thromboembolism/VTEExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Cumulative incidence of recurrent Venous Thromboembolism/VTE
Evaluate the cumulative incidence of recurrent Venous Thromboembolism/VTE at 6 months following discontinuation of anticoagulation in participants with low risk DNA liquid biopsy-based model.
Time frame
6 monthsSponsors and contacts
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Source ClinicalTrials.gov