A Nonrandomized Trial Using DNA Liquid Biopsies to Guide Anticoagulation For Patients With Cancer-Associated Thromboembolism
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.
• 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).