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Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism
Trial Status: active
This clinical trial evaluates whether a special blood test can be used with an algorithmic software tool to predict the likelihood of venous thromboembolism (VTE) in cancer patients and to make recommendations about whether a patient can stop taking anticoagulant medications. VTE is a disorder in which a blood clot (called a thrombus) forms in a blood vessel and may travel to another site in the body, such as the lungs, via the blood stream. Patients with cancer are at risk of developing cancer-associated VTE and are commonly prescribed anticoagulants, though the optimal duration of anticoagulation therapy for cancer-associated VTE is unknown. Studies have shown that a special type of deoxyribonucleic acid (DNA) called circulating tumor DNA (ctDNA), which can be measured in a patient's blood, is associated with risk of developing VTE and may be predictive of whether or not a patient needs to continue on anticoagulation therapy. In this trial, patients have a VTE risk score calculated, based on a machine learning or artificial intelligence algorithm, using their ctDNA test results. An algorithm is a set of instructions that a computer system uses to learn from data, find patterns, and make predictions or decisions. Based on their risk score, patients may be instructed to continue or discontinue their anticoagulation therapy. This ctDNA algorithm-based risk score may be an effective way to predict future VTE and make recommendations regarding the need for anticoagulation therapy in patients with cancer.
Inclusion Criteria
Age >= 18 with a history of cancer-associated VTE (objectively confirmed symptomatic or incidental/unsuspected proximal lower-limb deep vein thrombosis [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, computed tomography (CT) venography, or magnetic resonance (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
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT07399977.
Locations matching your search criteria
United States
New Jersey
Basking Ridge
Memorial Sloan Kettering Basking Ridge
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
Middletown
Memorial Sloan Kettering Monmouth
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
Montvale
Memorial Sloan Kettering Bergen
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
New York
Commack
Memorial Sloan Kettering Commack
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
New York
Memorial Sloan Kettering Cancer Center
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
Uniondale
Memorial Sloan Kettering Nassau
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
West Harrison
Memorial Sloan Kettering Westchester
Status: Active
Contact: Justin Jee
Phone: 646-608-4349
PRIMARY OBJECTIVE:
I. Evaluate the cumulative incidence of recurrent VTE at 6 months following discontinuation of anticoagulation in patients with low risk DNA liquid biopsy-based model.
SECONDARY OBJECTIVES:
I. Estimate the proportion of patients with the high and low risk of VTE based on the prediction model.
II. Estimate the risk of recurrent VTE in the high risk group continuing anticoagulation and estimate the difference in the risk between high risk group and the low risk group that stopped anticoagulation.
III. Describe the cumulative incidence of bleeding in the two cohorts.
EXPLORATORY OBJECTIVES:
I. Estimate risk of arterial thromboembolism in the two cohorts.
II. Describe mortality rates in the low and high risk cohorts.
III. Describe the cumulative incidence of recurrent VTE beyond 6 months in both groups using data collected as part of standard of care.
IV. Describe the cumulative incidence of recurrent VTE in the high and low risk groups at 6 months separately for patients with 3 to 6 months of prior anticoagulation and 6 to 12 months of prior anticoagulation.
V. Estimate discriminatory capacity of alternative biomarkers for recurrent VTE risk stratification.
OUTLINE: Patients undergo collection of a blood sample for ctDNA sequencing and algorithm-based risk determination. Patients determined to be at high risk for VTE are assigned to Arm I and patients determined to be at low risk for VTE are assigned to Arm II.
ARM I: Patients at high risk for VTE continue their standard of care (SOC) anticoagulation therapy. Patients also undergo collection of an additional plasma sample on study.
ARM II: Patients at low risk for VTE discontinue their SOC anticoagulation therapy. Patients also undergo collection of an additional plasma sample on study.
After completion of study intervention, patients are followed up at 30, 60, and 180 days.
Trial PhaseNo phase specified
Trial Typediagnostic
Lead OrganizationMemorial Sloan Kettering Cancer Center
