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
Qualifiers
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
Treatments tested in this trial
- MSK-ACCESS
- ctDNA/VTE Risk Score:
Treatment groups
259 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov