NCT03781531 Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism
| NCT ID | NCT03781531 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Danderyd Hospital |
| Condition | Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,000 participants |
| Start Date | 2017-03-01 |
| Primary Completion | 2022-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 1,000 participants in total. It began in 2017-03-01 with a primary completion date of 2022-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Venous thromboembolism is a common and serious complication in cancer, and is associated with a substantially increased morbidity and mortality. Furthermore, VTE may be the earliest sign of cancer. Recent studies, however, fail to show a clinical benefit of extended cancer screening in this patient population. Better risk prediction models are therefore warranted to identify VTE patients who would benefit from a rapid and extensive cancer screening. Inflammation and hypercoagulability are considered hallmarks of cancer, and emerging light is being shed on the potential of various markers of inflammation and coagulation in cancer diagnostics and prognostics. Among the inflammatory and thrombotic processes linked to cancer is the neutrophil release of web-like nuclear chromatin (DNA and histones), referred to as neutrophil extracellular traps (NETs). Driven by the tumor environment, NETs have recently been shown to play a central role in tumor progression, metastasis, and tumor-associated thrombosis. The investigators hypothesize that an enhanced inflammatory state may be predictive of an underlying cancer in patients presenting with VTE. The present study is an ongoing prospective study with the primary aim to investigate the diagnostic potential of markers of inflammation, including markers of NETs, in detecting occult cancer in patients presenting with VTE. Secondary aims are to include other biomarkers of cancer, and to assess whether any or a combination of these biomarkers may be prognostic of occult cancer, recurrent thrombotic events, mortality, or cancer disease progression in VTE patients with an underlying malignancy.
Eligibility Criteria
Inclusion Criteria: * Venous thromboembolism (thrombosis in the deep venous system of upper or lower extremities or iliac veins and/or pulmonary embolism) as detected by ultrasonography, phlebography, computer tomography, or angiography; * \> 18 years or older; * Written informed consent Exclusion Criteria: * \> 2 days after VTE diagnosis; * No blood withdrawal at baseline
Contact & Investigator
Charlotte Thålin, M.D., Ph.D.
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT03781531 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03781531 currently recruiting?
Yes, NCT03781531 is actively recruiting participants. Contact the research team at charlotte.thalin@sll.se for enrollment information.
Where is the NCT03781531 trial being conducted?
This trial is being conducted at Stockholm, Sweden, Stockholm, Sweden.
Who is sponsoring the NCT03781531 clinical trial?
NCT03781531 is sponsored by Danderyd Hospital. The principal investigator is Charlotte Thålin, M.D., Ph.D. at Karolinska Institutet. The trial plans to enroll 1,000 participants.
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