Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism
Recruiting now · Not applicable
Conditions studied: Venous Thromboembolism, Deep Venous Thrombosis
In brief
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.
Key facts
- Study ID
- NCT07399977
- Run by
- Memorial Sloan Kettering Cancer Center
- People needed
- 259
- Starts
- 2026-01-30
- Expected to finish
- 2030-01-30
- Last updated by the study team
- 2026-05-05
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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).
- 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).
You may not qualify if…
- 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
Where it is running
- Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities) — Basking Ridge, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale, New Jersey, United States (enrolling)
- Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack, New York, United States (enrolling)
- Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison, New York, United States (enrolling)
- Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York, New York, United States (enrolling)
- Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre, New York, United States (enrolling)
- Royal North Shore Hospital, Australia — Sydney, Australia
Full record on ClinicalTrials.gov
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