Blood test and software to guide treatment for venous thromboembolism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
  Basking Ridge, New Jersey, United States Recruiting
• Memorial Sloan Kettering Monmouth (All Protocol Activities)
  Middletown, New Jersey, United States Recruiting
• Memorial Sloan Kettering Bergen (All Protocol Activities)
  Montvale, New Jersey, United States Recruiting
• Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
  Commack, New York, United States Recruiting
• Memorial Sloan Kettering Westchester (All Protocol Activities)
  Harrison, New York, United States Recruiting
• Memorial Sloan Kettering Cancer Center (All Protocol Activites)
  New York, New York, United States Recruiting

Study contacts

• Principal investigator: Justine Jee, MD, PhD — Memorial Sloan Kettering Cancer Center
• Study coordinator: Justin Jee, MD, PhD
• Email: jeej@mskcc.org
• Phone: 646-608-4409

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.