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NCT Number: NCT03781531

Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism

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.

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Danderyd Hospital, Stockholm, Sweden

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Cancer

    Time frame: Within 2 years from study inclusion

    Patients diagnosed with VTE will be referred for a limited cancer screening according to current guidelines. Cancer diagnosis - if not present at inclusion - will be obtained during a two-year follow-up from hospital records and/or the Swedish cancer registry

Secondary outcomes

  1. Recurrent thrombotic event

    Time frame: Within 2 years from study inclusion

    Recurrent thrombotic event (arterial or venous thrombosis) will be obtained during a two-year follow-up from hospital records and/or the Swedish national patient registry

  2. All-cause mortality

    Time frame: Within 2 years from study inclusion

    All-cause mortality will be obtained during a two-year follow-up from hospital records and/or the Swedish death registry

  3. Cancer progression among enrolled patients with a cancer diagnosis at study inclusion

    Time frame: Within 2 years from study inclusion

    Patients with cancer progression will be identified during a two-year follow-up from hospital records and/or the Swedish cancer registry

Study contacts

Contact information is provided by the study sponsor or research team.

Charlotte Thålin, M.D., Ph.D.

CONTACT

[email protected]

+46709565120

Håkan Wallén, M.D., Prof.

CONTACT

[email protected]

+46707374935

Sponsors and collaborators

Lead sponsor

Danderyd Hospital

Other

Collaborators

  • Karolinska Institutet

Registry information

Important dates

Study start
2017
Primary completion
2022
Study completion
2028
First posted
Dec 20, 2018
Registry last updated
Dec 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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