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

NCT ID: NCT03781531

Last Updated: 2018-12-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-01

Study Completion Date

2028-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cancer Venous Thromboembolism

Keywords

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Occult cancer Venous thromboembolism Biomarkers Early diagnosis Neutrophil extracellular traps

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Venous thromboembolism

Patients presenting with 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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role collaborator

Danderyd Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Charlotte Thålin, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Håkan Wallén, M.D., Prof.

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Danderyd Hospital

Stockholm, , Sweden

Site Status RECRUITING

Södersjukhuset

Stockholm, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Charlotte Thålin, M.D., Ph.D.

Role: CONTACT

Phone: +46709565120

Email: [email protected]

Håkan Wallén, M.D., Prof.

Role: CONTACT

Phone: +46707374935

Email: [email protected]

Facility Contacts

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Charlotte Thålin, M.D., Ph.D.

Role: primary

Lena Gabrielsson

Role: backup

Mårten Söderberg, M.D., Ph.D.

Role: primary

Other Identifiers

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dnr2017/260-31/4

Identifier Type: -

Identifier Source: org_study_id