Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorMemorial Sloan Kettering Cancer Center

About this trial

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.

Eligibility criteria

Qualifiers

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).

breast cancer regardless of cytotoxic-chemotherapy status

hepatobiliary cancer regardless of cytotoxic-chemotherapy status

prostate cancer regardless of cytotoxic-chemotherapy status

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • MSK-ACCESS
  • ctDNA/VTE Risk Score:

Treatment groups

259 Participants
are divided into 2 treatment groups

Locations

8
Australia
Royal North Shore Hospital, Australia2065, Sydney Australia
United States
Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)07920, Basking RidgeNew Jersey, United States
Memorial Sloan Kettering Monmouth (All Protocol Activities)07748, MiddletownNew Jersey, United States
Memorial Sloan Kettering Bergen (All Protocol Activities)07645, MontvaleNew Jersey, United States

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor