A Nonrandomized Trial Using DNA Liquid Biopsies to Guide Anticoagulation For Patients With Cancer-Associated Thromboembolism
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 259
- 试验地点
- 8
- 主要终点
- Cumulative incidence of recurrent Venous Thromboembolism/VTE
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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).
排除标准
- •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
研究组 & 干预措施
Low-risk for recurrent Venous Thromboembolism/VTE
Participants with a ≤5% chance of Venous Thromboembolism/VTE according to the model will be designated "low risk" for the purposes of the study; all other participants will be considered "high risk.
干预措施: ctDNA/VTE Risk Score: (Diagnostic Test)
High risk for recurrent Venous Thromboembolism/VTE
Participants with a ≤5% chance of Venous Thromboembolism/VTE according to the model will be designated "low risk" for the purposes of the study; all other participants will be considered "high risk.
干预措施: MSK-ACCESS (Diagnostic Test)
High risk for recurrent Venous Thromboembolism/VTE
Participants with a ≤5% chance of Venous Thromboembolism/VTE according to the model will be designated "low risk" for the purposes of the study; all other participants will be considered "high risk.
干预措施: ctDNA/VTE Risk Score: (Diagnostic Test)
Low-risk for recurrent Venous Thromboembolism/VTE
Participants with a ≤5% chance of Venous Thromboembolism/VTE according to the model will be designated "low risk" for the purposes of the study; all other participants will be considered "high risk.
干预措施: MSK-ACCESS (Diagnostic Test)
结局指标
主要结局
Cumulative incidence of recurrent Venous Thromboembolism/VTE
时间窗: 6 months
Evaluate the cumulative incidence of recurrent Venous Thromboembolism/VTE at 6 months following discontinuation of anticoagulation in participants with low risk DNA liquid biopsy-based model.
次要结局
未报告次要终点