Actively Recruiting
A Nonrandomized Trial Using DNA Liquid Biopsies to Guide Anticoagulation for Patients With Cancer-Associated Thromboembolism
Led by Memorial Sloan Kettering Cancer Center · Updated on 2026-05-05
259
Participants Needed
8
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating whether a software tool called the ctDNA/VTE risk score model can effectively predict the chance of Venous Thromboembolism (VTE) returning in people who have already received blood-thinning treatment. This study focuses on adults with cancer-associated VTE, including deep venous thrombosis or pulmonary embolism, aiming to guide future anticoagulant treatment decisions. The trial is sponsored by Memorial Sloan Kettering Cancer Center and is a nonrandomized interventional study. Participants will undergo testing using MSK-ACCESS, a ctDNA sequencing assay, combined with a machine learning-based VTE risk score. Based on the model, participants are classified as either "low risk" (5% or less chance of VTE recurrence) or "high risk" (greater than 5% chance). This classification guides their management within the study. The study does not involve randomization or blinding and categorizes participants into two experimental arms based on their risk level. Throughout the study, participants will be monitored for the main outcome, which is the cumulative incidence of recurrent VTE over six months. The study involves regular assessments to track VTE recurrence. Participants are adults aged 18 or older with a history of cancer-related VTE who have completed anticoagulation therapy between 3 and 12 months. The total duration and detailed follow-up procedures will be according to the study protocol ending in 2030.
CONDITIONS
Brief Title
Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older with a history of cancer-associated VTE confirmed by imaging
- Completed between 3 and 12 months of anticoagulation treatment with enoxaparin, dalteparin, rivaroxaban, or apixaban without current VTE symptoms
- Diagnosis of objectively confirmed symptomatic or incidental proximal lower-limb deep venous thrombosis (DVT) or pulmonary embolism (PE)
- Diagnosis of one of the following solid tumors in advanced stage or receiving systemic anticancer treatment within six weeks of enrollment: breast cancer, hepatobiliary cancer, prostate cancer, non-small cell lung cancer, pancreatic cancer, or bladder cancer
- Signed and dated informed consent by participant or legally authorized representative
You will not qualify if you...
- Contraindication to ongoing anticoagulation
- Contraindication to stopping anticoagulation (e.g., known antiphospholipid syndrome, factor V Leiden, active arterial thrombus, catheter-associated thrombus, anticoagulation for atrial fibrillation or other non-cancer reasons)
- History of major bleeding in the last six months
- Known diagnosis of disseminated intravascular coagulation (DIC)
- Suspicion of tumor thrombus on imaging at original VTE diagnosis
- Enrolled in hospice care
- Currently has an inferior vena cava (IVC) filter
- Diagnosis of an active hematologic malignancy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Single assessment around enrollment
Participants undergo blood tests and software analysis to assess their risk of recurrent Venous Thromboembolism (VTE) using DNA liquid biopsies and machine learning risk scores.
1 visit (in-person)
Duration - 6 months
Participants are observed for up to 6 months to monitor for any recurrent Venous Thromboembolism (VTE) events.
Periodic visits over 6 months depending on clinical need
Trial Site Locations
Total: 8 locations
1
Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, United States, 07920
Actively Recruiting
2
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, United States, 07748
Actively Recruiting
3
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, United States, 07645
Actively Recruiting
4
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, United States, 11725
Actively Recruiting
5
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, United States, 10604
Actively Recruiting
6
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, United States, 10065
Actively Recruiting
7
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, United States, 11553
Actively Recruiting
8
Royal North Shore Hospital, Australia
Sydney, Australia, 2065
Not Yet Recruiting
Research Team
J
Justin Jee, MD, PhD
J
Jeffrey Zwicker, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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