NCT07399977

Brief Summary

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
259

participants targeted

Target at P75+ for not_applicable

Timeline
44mo left

Started Jan 2026

Longer than P75 for not_applicable

Geographic Reach
2 countries

8 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress9%
Jan 2026Jan 2030

Study Start

First participant enrolled

January 30, 2026

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

February 3, 2026

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 10, 2026

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2030

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2030

Last Updated

May 5, 2026

Status Verified

May 1, 2026

Enrollment Period

4 years

First QC Date

February 3, 2026

Last Update Submit

May 4, 2026

Conditions

Venous ThromboembolismDeep Venous Thrombosis

Keywords

Venous ThromboembolismDeep Venous Thrombosis25-095Memorial Sloan Kettering Cancer Center

Outcome Measures

Primary Outcomes (1)

  • Cumulative incidence of recurrent Venous Thromboembolism/VTE

    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

Study Arms (2)

High risk for recurrent Venous Thromboembolism/VTE

EXPERIMENTAL

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-ACCESSDiagnostic Test: ctDNA/VTE Risk Score:

Low-risk for recurrent Venous Thromboembolism/VTE

EXPERIMENTAL

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-ACCESSDiagnostic Test: ctDNA/VTE Risk Score:

Interventions

MSK-ACCESSDIAGNOSTIC_TEST

MSK-ACCESS is a ctDNA sequencing assay

High risk for recurrent Venous Thromboembolism/VTELow-risk for recurrent Venous Thromboembolism/VTE
ctDNA/VTE Risk Score:DIAGNOSTIC_TEST

Machine learning Venous Thromboembolism/VTE risk score mode

High risk for recurrent Venous Thromboembolism/VTELow-risk for recurrent Venous Thromboembolism/VTE

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (8)

Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)

Basking Ridge, New Jersey, 07920, United States

RECRUITING

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Middletown, New Jersey, 07748, United States

RECRUITING

Memorial Sloan Kettering Bergen (All Protocol Activities)

Montvale, New Jersey, 07645, United States

RECRUITING

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Commack, New York, 11725, United States

RECRUITING

Memorial Sloan Kettering Westchester (All Protocol Activities)

Harrison, New York, 10604, United States

RECRUITING

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

New York, New York, 10065, United States

RECRUITING

Memorial Sloan Kettering Nassau (All protocol activities)

Rockville Centre, New York, 11553, United States

RECRUITING

Royal North Shore Hospital, Australia

Sydney, 2065, Australia

NOT YET RECRUITING

Related Links

MeSH Terms

Conditions

Venous ThromboembolismVenous Thrombosis

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesThrombosis

Study Officials

  • Justine Jee, MD, PhD

    Memorial Sloan Kettering Cancer Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Justin Jee, MD, PhD

CONTACT

646-608-4409jeej@mskcc.org

Jeffrey Zwicker, MD

CONTACT

646-608-3723zwickerj@mskcc.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 3, 2026

First Posted

February 10, 2026

Study Start

January 30, 2026

Primary Completion (Estimated)

January 30, 2030

Study Completion (Estimated)

January 30, 2030

Last Updated

May 5, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will share

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.

Locations

US(7)AU(1)