Deep Venous Thrombosis, Venous Thromboembolism
Conditions
Keywords
Venous Thromboembolism, Deep Venous Thrombosis, 25-095, Memorial Sloan Kettering Cancer Center
Brief summary
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.
Interventions
DIAGNOSTIC_TESTMSK-ACCESS
MSK-ACCESS is a ctDNA sequencing assay
DIAGNOSTIC_TESTctDNA/VTE Risk Score:
Machine learning Venous Thromboembolism/VTE risk score mode
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cumulative incidence of recurrent Venous Thromboembolism/VTE | 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. |
Countries
Australia, United States
Contacts
CONTACTJustin Jee, MD, PhD
CONTACTJeffrey Zwicker, MD
PRINCIPAL_INVESTIGATORJustine Jee, MD, PhD
Memorial Sloan Kettering Cancer Center
Outcome results
None listed