Recruiting

ctDNA/VTE Risk ScoreUsing a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism

Sponsor:

Memorial Sloan Kettering Cancer Center

Code:

NCT07399977

Conditions

Venous Thromboembolism

Deep Venous Thrombosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MSK-ACCESS

ctDNA/VTE Risk Score:

Study Details

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.

Conditions

Venous Thromboembolism

Deep Venous Thrombosis

Study ID

NCT07399977

Start date

Jan 30, 2026

Status verified date

May, 2026

Completion date

Jan 30, 2030

Anticipated

Primary completion date

Jan 30, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

259 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

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.

experimental: Low-risk for recurrent Venous Thromboembolism/VTE

Interventions

MSK-ACCESS

MSK-ACCESS is a ctDNA sequencing assay

ctDNA/VTE Risk Score:

Machine learning Venous Thromboembolism/VTE risk score mode

Primary outcome measure

Cumulative incidence of recurrent Venous Thromboembolism/VTE [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Justin Jee, MD, PhD

646-608-4409 jeej@mskcc.org

Jeffrey Zwicker, MD

646-608-3723 zwickerj@mskcc.org

Locations

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

Recruiting

Basking Ridge, New Jersey, United States, 07920

Contacts

Justin Jee, MD, PhD

646-608-4409

Memorial Sloan Kettering Monmouth (All Protocol Activities)

Recruiting

Middletown, New Jersey, United States, 07748

Contacts

Justin Jee, MD, PhD

646-608-4409

Memorial Sloan Kettering Bergen (All Protocol Activities)

Recruiting

Montvale, New Jersey, United States, 07645

Contacts

Justin Jee, MD, PhD

646-608-4409

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)

Recruiting

Commack, New York, United States, 11725

Contacts

Justin Jee, MD, PhD

646-608-4409

Memorial Sloan Kettering Westchester (All Protocol Activities)

Recruiting

Harrison, New York, United States, 10604

Contacts

Justin Jee, MD, PhD

646-608-4409

Memorial Sloan Kettering Cancer Center (All Protocol Activites)

Recruiting

New York, New York, United States, 10065

Contacts

Justin Jee, MD, PhD

646-608-4409

Memorial Sloan Kettering Nassau (All protocol activities)

Recruiting

Rockville Centre, New York, United States, 11553

Contacts

Justin Jee, MD, PhD

646-608-4409

More Information

Sponsor

Memorial Sloan Kettering Cancer Center

Last update posted

May 5, 2026

Last verified

May, 2026

Keywords

Venous Thromboembolism
Deep Venous Thrombosis
25-095
Memorial Sloan Kettering Cancer Center

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Memorial Sloan Kettering Cancer Center on 2026-05-05.