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

May 4, 2026 updated by: Memorial Sloan Kettering Cancer Center

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

259

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Justin Jee, MD, PhD
  • Phone Number: 646-608-4409
  • Email: jeej@mskcc.org

Study Locations

  • Australia
      • Sydney, Australia, 2065
        • Not yet recruiting
        • Royal North Shore Hospital, Australia
        • Contact:
          • Adrian Lee, MBBS, FRACP PhD
          • Phone Number: 02 8037 4100
  • United States
    • New Jersey
      • Basking Ridge, New Jersey, United States, 07920
        • Recruiting
        • Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409
      • Middletown, New Jersey, United States, 07748
        • Recruiting
        • Memorial Sloan Kettering Monmouth (All protocol activities)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409
      • Montvale, New Jersey, United States, 07645
        • Recruiting
        • Memorial Sloan Kettering Bergen (All protocol activities)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409
    • New York
      • Commack, New York, United States, 11725
        • Recruiting
        • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409
      • Harrison, New York, United States, 10604
        • Recruiting
        • Memorial Sloan Kettering Westchester (All protocol activities)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409
      • New York, New York, United States, 10065
        • Recruiting
        • Memorial Sloan Kettering Cancer Center (All Protocol Activites)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409
      • Rockville Centre, New York, United States, 11553
        • Recruiting
        • Memorial Sloan Kettering Nassau (All protocol activities)
        • Contact:
          • Justin Jee, MD, PhD
          • Phone Number: 646-608-4409

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High risk for recurrent Venous Thromboembolism/VTE
Participants with a ≤5% chance of Venous Thromboembolism/VTE according to the model will be designated "low risk" for the purposes of the study; all other participants will be considered "high risk.
Diagnostic test: MSK-ACCESS
MSK-ACCESS is a ctDNA sequencing assay
Diagnostic test: ctDNA/VTE Risk Score:
Machine learning Venous Thromboembolism/VTE risk score mode
Experimental: Low-risk for recurrent Venous Thromboembolism/VTE
Participants with a ≤5% chance of Venous Thromboembolism/VTE according to the model will be designated "low risk" for the purposes of the study; all other participants will be considered "high risk.
Diagnostic test: MSK-ACCESS
MSK-ACCESS is a ctDNA sequencing assay
Diagnostic test: ctDNA/VTE Risk Score:
Machine learning Venous Thromboembolism/VTE risk score mode

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cumulative incidence of recurrent Venous Thromboembolism/VTE
Time Frame: 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.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Memorial Sloan Kettering Cancer Center

Investigators

  • Principal Investigator: Justine Jee, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 30, 2026

Primary Completion (Estimated)

January 30, 2030

Study Completion (Estimated)

January 30, 2030

Study Registration Dates

First Submitted

February 3, 2026

First Submitted That Met QC Criteria

February 3, 2026

First Posted (Actual)

February 10, 2026

Study Record Updates

Last Update Posted (Actual)

May 5, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 25-095

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made following one year after publication and for up to 36 months later. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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