Blood Test and Software Tool for Venous Thromboembolism

Recruiting at 7 trial locations

Overseen By Jeffrey Zwicker, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Memorial Sloan Kettering Cancer Center

Must be taking: Anticoagulants

Disqualifiers: Major bleeding, DIC, Hospice, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 6 months

259 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Justine Jee, MD, PhD

Principal Investigator

Memorial Sloan Kettering Cancer Center

Are You a Good Fit for This Trial?

This trial is for adults over 18 with a history of cancer-associated venous thromboembolism (VTE), such as deep vein thrombosis or pulmonary embolism, who have completed 3-12 months of anticoagulation treatment. It's open to patients with specific cancers including hepatobiliary, prostate, breast, non-small cell lung cancer treated with chemotherapy within the last 30 days, pancreatic and bladder cancers similarly treated.

Inclusion Criteria

I have liver or bile duct cancer.

I am over 18, had a blood clot related to cancer, and finished 3-12 months of specific blood thinner treatment without current symptoms.

I have prostate cancer, treatment status doesn't matter.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive anticoagulant treatment guided by the ctDNA/VTE risk score model

6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

What Are the Treatments Tested in This Trial?

Interventions

• ctDNA/VTE Risk Score

Trial Overview

The study is testing a software tool called ctDNA/VTE risk score model designed to predict the chance of VTE recurrence in patients after they've received blood-thinning treatments. The goal is to see if this tool can effectively guide future treatment decisions.

How Is the Trial Designed?

Group I: Low-risk for recurrent Venous Thromboembolism/VTE Experimental Treatment 2 Interventions

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.

Group II: High risk for recurrent Venous Thromboembolism/VTE Experimental Treatment 2 Interventions

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.

Who Is Running the Clinical Trial?

Memorial Sloan Kettering Cancer Center

Lead Sponsor

Trials

1,998

Recruited

602,000+