Blood Test and Software Tool for Venous Thromboembolism
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to determine if a new software tool, the ctDNA/VTE Risk Score, can predict the recurrence of venous thromboembolism (VTE) in individuals previously treated for it. The tool uses a blood test to assess risk. Individuals who have experienced a cancer-related blood clot and completed blood-thinning treatment may qualify for this study. Researchers divide participants into "high risk" or "low risk" groups based on their predicted chance of clot recurrence. As an unphased trial, this study offers participants the chance to contribute to innovative research that could enhance future VTE risk assessments.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, it seems that participants should have completed anticoagulation treatment before joining the study.
What prior data suggests that this software tool is safe for predicting VTE recurrence?
Research has shown that a test called ctDNA (circulating tumor DNA) is a promising method for assessing the risk of venous thromboembolism (VTE), which occurs when blood clots form in veins. Studies have found that ctDNA testing can help doctors better predict and manage this risk, particularly in cancer patients.
Real-world data indicates that when ctDNA is detected and blood-thinning treatments are used, VTE rates decrease. This suggests the test could guide treatments to prevent the recurrence of blood clots.
Although these studies focus on risk prediction rather than direct treatment, no serious safety issues have been reported from using the ctDNA test itself. This suggests that the ctDNA/VTE risk score model is safe and well-tolerated for assessing blood clot risks.12345Why are researchers excited about this trial?
Researchers are excited about this trial because it explores a novel way to assess the risk of venous thromboembolism (VTE) using a combination of a blood test and a software tool. Unlike current treatments, which typically focus on managing symptoms with blood thinners or anticoagulants, this approach aims to predict the likelihood of VTE recurrence. By identifying individuals at high or low risk, this method could lead to more personalized and effective prevention strategies, potentially reducing the need for long-term medication in low-risk patients and enhancing treatment plans for those at higher risk.
What evidence suggests that this software tool is effective for predicting recurrent Venous Thromboembolism?
Research has shown that a blood test for ctDNA (circulating tumor DNA) can help predict the risk of blood clots (venous thromboembolism or VTE) returning. In this trial, participants will be categorized into different risk groups based on their ctDNA/VTE risk score. Studies have found that detecting ctDNA and using blood-thinning treatments can reduce the chance of VTE recurrence by about half. Identifying ctDNA can help pinpoint individuals more likely to experience VTE again. Additionally, using ctDNA testing alongside other risk assessment tools in cancer patients may improve VTE prediction. Thus, the ctDNA/VTE risk score model could offer a promising approach to customize treatment and prevent VTE recurrence.14678
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive anticoagulant treatment guided by the ctDNA/VTE risk score model
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
2
Treatment groups
Experimental Treatment
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.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Memorial Sloan Kettering Cancer Center
Lead Sponsor
Citations
DNA liquid biopsy-based prediction of cancer-associated ...
In real-world data, anticoagulation was associated with lower VTE rates if ctDNA was detected (n = 2,522, adjusted hazard ratio (HR) = 0.50, 95% ...
Circulating tumor DNA predicts venous thromboembolism ...
Specifically, the incidence of VTE at 6 months was 5.5% (95% CI, 1.8%-9.2%) without ctDNA mutations, 6.3% (95% CI, 3.3%-9.3%) for VUS only, 6.8% (95% CI, 3.7%- ...
Circulating tumor DNA predicts venous thromboembolism ...
Combined analysis of clinical and laboratory markers to predict the risk of venous thromboembolism in patients with IDH1 wild-type glioblastoma
Circulating tumor DNA predicts venous thromboembolism in ...
Conclusions: ctDNA testing may serve as an adjunctive tool to clinical risk assessment models in cancer patients to improve personalized VTE ...
Using a Blood Test and Software Tool to Guide Treatment ...
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 ...
Circulating tumor DNA predicts venous thromboembolism ...
ctDNA testing may serve as an adjunctive tool to clinical risk assessment models in cancer patients to improve personalized VTE risk assessment and management.
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ashpublications.org
ashpublications.org/blood/article/144/Supplement%201/4013/529778/Circulating-Tumor-DNA-Predicts-VenousCirculating Tumor DNA Predicts Venous Thromboembolism in ...
This study investigated the association between ctDNA and VTE risk in a diverse cohort of cancer patients.
Circulating tumor DNA predicts venous thromboembolism in ...
Conclusion: ctDNA testing may serve as an adjunctive tool to clinical risk assessment models in cancer patients to improve personalized VTE risk ...
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