Venous ThromboembolismNCT07399977
Using a Blood Test and Software Tool to Guide Treatment for Venous Thromboembolism
A study testing MSK-ACCESS and ctDNA/VTE Risk Score: in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Memorial Sloan Kettering Cancer Center at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Deep Venous Thrombosis
- What is being tested?
- MSK-ACCESS and ctDNA/VTE Risk Score:
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 259 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 30 Jan 2026to 30 Jan 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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).
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 2 countries
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center Basking Ridge (All Protocol Activities)
Basking Ridge, New Jersey, 07920
Justin Jee, MD, PhD, 646-608-4409
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities)
Commack, New York, 11725
Justin Jee, MD, PhD, 646-608-4409
- Recruiting
Memorial Sloan Kettering Westchester (All Protocol Activities)
Harrison, New York, 10604
Justin Jee, MD, PhD, 646-608-4409
- Recruiting
Memorial Sloan Kettering Monmouth (All Protocol Activities)
Middletown, New Jersey, 07748
Justin Jee, MD, PhD, 646-608-4409
- Recruiting
Memorial Sloan Kettering Bergen (All Protocol Activities)
Montvale, New Jersey, 07645
Justin Jee, MD, PhD, 646-608-4409
- Recruiting
Memorial Sloan Kettering Cancer Center (All Protocol Activites)
New York, New York, 10065
Justin Jee, MD, PhD, 646-608-4409
- Recruiting
Memorial Sloan Kettering Nassau (All protocol activities)
Rockville Centre, New York, 11553
Justin Jee, MD, PhD, 646-608-4409
Australia1 site, 1 recruiting
- Not yet recruiting
Royal North Shore Hospital, Australia
Sydney, 2065
Adrian Lee, MBBS, FRACP PhD, 02 8037 4100
About this study
Official title: A Nonrandomized Trial Using DNA Liquid Biopsies to Guide Anticoagulation For Patients With Cancer-Associated Thromboembolism
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
- Being tested
- MSK-ACCESS, ctDNA/VTE Risk Score:
- Keywords
- Venous Thromboembolism, Deep Venous Thrombosis, 25-095, Memorial Sloan Kettering Cancer Center
- Medical subject headings
- Venous Thromboembolism, Venous Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSK-ACCESSDiagnostic test
MSK-ACCESS is a ctDNA sequencing assay
ctDNA/VTE Risk Score:Diagnostic test
Machine learning Venous Thromboembolism/VTE risk score mode
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MSK-ACCESS; Diagnostic 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. Receives: Diagnostic Test: MSK-ACCESS; Diagnostic Test: ctDNA/VTE Risk Score: |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2026
- Study start30 Jan 2026
- Primary completion30 Jan 2030 (estimated)
- Study completion30 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 259 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Justine Jee, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07399977
- Sponsor's protocol ID
- 25-095
- Status last verified
- May 2026
- First submitted
- 3 Feb 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Nonrandomized Trial Using DNA Liquid Biopsies to Guide Anticoagulation For Patients With Cancer-Associated Thromboembolism
- ClinicalTrials.gov ID
- NCT07399977
- Acronym / sponsor ID
- 25-095
- Conditions
- Venous Thromboembolism, Deep Venous Thrombosis
- Keywords
- Venous Thromboembolism, Deep Venous Thrombosis, 25-095, Memorial Sloan Kettering Cancer Center
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 259 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 30 Jan 2026 (actual)
- Primary completion
- 30 Jan 2030 (estimated)
- Study completion
- 30 Jan 2030 (estimated)
- First posted
- 10 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High risk for recurrent Venous Thromboembolism/VTE | Experimental | Diagnostic Test: MSK-ACCESS, Diagnostic Test: ctDNA/VTE Risk Score: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. |
| Low-risk for recurrent Venous Thromboembolism/VTE | Experimental | Diagnostic Test: MSK-ACCESS, Diagnostic Test: ctDNA/VTE Risk Score: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 may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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):
- Signed and dated informed consent by study participant/Legally Authorized Representative (LAR).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSK-ACCESSMSK-ACCESS is a ctDNA sequencing assay | Diagnostic test | High risk for recurrent Venous Thromboembolism/VTE, Low-risk for recurrent Venous Thromboembolism/VTE |
| ctDNA/VTE Risk Score:Machine learning Venous Thromboembolism/VTE risk score mode | Diagnostic test | High risk for recurrent Venous Thromboembolism/VTE, Low-risk for recurrent Venous Thromboembolism/VTE |
Primary outcome
Cumulative incidence of recurrent Venous Thromboembolism/VTE
Time frame: 6 months
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Justine Jee, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MSK-ACCESS and ctDNA/VTE Risk Score: in people with Venous Thromboembolism and Deep Venous Thrombosis, run by Memorial Sloan Kettering Cancer Center at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Justin Jee, MD, PhD (646-608-4409, jeej@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of recurrent Venous Thromboembolism/VTE (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.