Clinical trial NCT03781531: Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism
Official title: Identification of Novel Biomarkers to Aid in the Detection of Occult Cancer in Patients With Venous Thromboembolism
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cancer
Venous Thromboembolism
Keywords: Occult cancer
Venous thromboembolism
Biomarkers
Early diagnosis
Neutrophil extracellular traps
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Karolinska Institutet
First posted: 2018-12-20
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Consecutive patients age \>18 years with objectively confirmed venous thromboembolism (thrombosis in the deep venous system of upper or lower extremities or iliac veins and/or pulmonary embolism) diagnosed \< 2 days.

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

Primary outcomes:
measure: Cancer
timeFrame: Within 2 years from study inclusion
Secondary outcomes:
measure: Recurrent thrombotic event
timeFrame: Within 2 years from study inclusion
measure: All-cause mortality
timeFrame: Within 2 years from study inclusion
measure: Cancer progression among enrolled patients with a cancer diagnosis at study inclusion
timeFrame: Within 2 years from study inclusion
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
city: Stockholm
country: Sweden
facility: Södersjukhuset
Study officials:
affiliation: Karolinska Institutet
name: Charlotte Thålin, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Karolinska Institutet
name: Håkan Wallén, M.D., Prof.
role: PRINCIPAL_INVESTIGATOR
References: