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Recruiting NCT07399977

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

No phase Interventional Venous Thromboembolism Deep Venous Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MSK-ACCESS, ctDNA/VTE Risk Score:.
Who it may be relevant to
Registry conditions: Venous Thromboembolism, Deep Venous Thrombosis. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States, Australia
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • 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

Primary outcome measures

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

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Diagnostic

Study locations

United States · 7 centers
  • Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities) — Basking Ridge
  • Memorial Sloan Kettering Monmouth (All Protocol Activities) — Middletown
  • Memorial Sloan Kettering Bergen (All Protocol Activities) — Montvale
  • Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities) — Commack
  • Memorial Sloan Kettering Westchester (All Protocol Activities) — Harrison
  • Memorial Sloan Kettering Cancer Center (All Protocol Activites) — New York
  • Memorial Sloan Kettering Nassau (All protocol activities) — Rockville Centre
Australia · 1 center
  • Royal North Shore Hospital, Australia — Sydney

Identifiers

NCT: NCT07399977 · 25-095

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗