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Blood test and software to guide treatment for venous thromboembolism

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

Not applicable Interventional Memorial Sloan Kettering Cancer Center · NCT07399977

This project tests whether a blood-based ctDNA test combined with a software risk score can predict if VTE will come back in adults with cancer-associated DVT or PE who have finished 3–12 months of anticoagulation.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment259 (estimated)
Ages18 Years and up
SexAll
SponsorMemorial Sloan Kettering Cancer Center Academic / other
Drugs / interventionschemotherapy
Locations8 sites (Basking Ridge, New Jersey and 7 other locations)
Trial IDNCT07399977 on ClinicalTrials.gov

What this trial studies

The intervention uses the MSK-ACCESS circulating tumor DNA test together with a ctDNA/VTE risk score software tool to estimate the chance of recurrent venous thromboembolism. Adults with cancer-associated proximal DVT or segmental-or-more-proximal PE who have completed between 3 and 12 months of anticoagulation are enrolled and undergo blood testing. The risk score output is intended to inform whether ongoing anticoagulation should be continued or altered, and outcomes such as recurrence will be tracked. All protocol activities are conducted at Memorial Sloan Kettering locations in New Jersey.

Who should consider this trial

Good fit: Adults (≥18) with cancer-associated proximal lower-limb DVT or segmental-or-larger PE who have completed 3–12 months of anticoagulation and are currently without VTE symptoms are ideal candidates.

Not a fit: Patients without active solid tumors or cancer-associated VTE, those with ongoing symptomatic VTE, or those unable to attend the MSK New Jersey sites are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could help tailor anticoagulation duration so patients at low risk can stop blood thinners sooner and high-risk patients can be protected from recurrence.

How similar studies have performed: While clinical risk scores for VTE recurrence exist, combining ctDNA measurement with a software risk model to guide anticoagulation is a novel approach with limited prior data.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Basking Ridge, New Jersey and 7 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Venous ThromboembolismDeep Venous Thrombosis25-095Memorial Sloan Kettering Cancer Center
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.