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Recruiting Not applicable NCT07399977

Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism

No applicable phase (e.g. observational)
Conditions: Venous Thromboembolism Deep Venous Thrombosis

Sponsor: Memorial Sloan Kettering Cancer Center

trial.available_in: БГ
Overview
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.
Who can participate
Inclusion Criteria: * 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 a therapeutic dosing of enoxaparin, dalteparin,rivaroxaban, or apixaban without current VTE-related symptoms (imaging to confirm resolution not required). Diagnosis of DVT requires evidence of one or more filling defects at compression ultrasonography, venography, CT venography, or MR venography involving at least the popliteal or more proximal veins. Diagnosis of PE requires an intraluminal filling defect in segmental or more proximal arteries. * Diagnosis of one of the following solid tumors in either advanced (i.e. unresectable) stage or receiving systemic anticancer treatment within six weeks of enrollment (maintenance therapy included): * breast cancer regardless of cytotoxic-chemotherapy status * hepatobiliary cancer regardless of cytotoxic-chemotherapy status * prostate cancer regardless of cytotoxic-chemotherapy status * non-small cell lung cancer with cytotoxic-chemotherapy received within 30 days * pancreatic cancer with cytotoxic-chemotherapy received within 30 days * bladder cancer with cytotoxic-chemotherapy received within 30 days * Signed and dated informed consent by study participant/Legally Authorized Representative (LAR). Exclusion Criteria: * 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) * Suspicion for tumor thrombus on the imaging leading to original diagnosis of VTE * Enrolled in hospice care * Currently has inferior vena cava (IVC) filter * Diagnosis of an active hematologic malignancy
Locations 2
Australia (1)
Royal North Shore Hospital, Australia
Sydney
NOT_YET_RECRUITING
Adrian Lee, MBBS, FRACP PhD
United States (1)
Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
Basking Ridge , New Jersey
Justin Jee, MD, PhD
Technical details
Status
Recruiting
Phase
Not applicable
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
30.01.2026
Completion date
30.01.2030
Registry ID
NCT07399977
Source
anzctr
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