Blood Test and Software Tool for Venous Thromboembolism

This study is testing if a software tool called ctDNA/VTE (Venous Thromboembolism) risk score, used with a blood test called MSK-ACCESS, can effectively predict if blood clots (VTE) will return in people who have had cancer-associated VTE. You may be able to join if you are 18 or older, have a history of cancer-associated VTE, and have completed 3 to 12 months of specific blood thinner treatments like enoxaparin, dalteparin, rivaroxaban, or apixaban. The study aims to see if using this tool can reduce the number of recurrent VTE events within 6 months. The current status of this study is unclear.

Study design
This is an interventional study with a planned enrollment of 259 participants. It is testing a diagnostic test.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed to measure the incidence of recurrent VTE at 6 months.

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NCT07399977

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

Recruiting
NAAges 18+InterventionalDiagnostic
Memorial Sloan Kettering Cancer Center
~259 participants
Updated 2026-05-05 on ClinicalTrials.gov
What's tested:MSK-ACCESSctDNA/VTE Risk Score:

At a glance

Recruiting sites
7 of 8 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Cumulative incidence of recurrent Venous Thromboembolism/VTE
Measured over 6 months
Venous Thromboembolism
Deep Venous Thrombosis
8 sites across 3 states
New York4
New Jersey3
Australia1
  • Justine Jee, MD, PhD · PRINCIPAL_INVESTIGATOR · Memorial Sloan Kettering Cancer Center

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Eligibility criteria

Inclusion

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 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

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
  • Cumulative incidence of recurrent Venous Thromboembolism/VTE6 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.