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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03781531
• Other study ID #: dnr2017/260-31/4
• Status: Recruiting
• Start date: March 1, 2017
• Est. completion date: December 31, 2028

Study information

• Verified date: December 2018
• Source: Danderyd Hospital
• Contact: Charlotte Thålin, M.D., Ph.D.
• Phone: +46709565120
• Email: charlotte.thalin[@]sll.se
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer
• Thromboembolism
• Venous Thromboembolism

Locations

Country	Name	City	State
Sweden	Danderyd Hospital	Stockholm
Sweden	Södersjukhuset	Stockholm

Sponsors (2)

Lead Sponsor	Collaborator
Danderyd Hospital	Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cancer	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	Within 2 years from study inclusion
Secondary	Recurrent thrombotic event	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	Within 2 years from study inclusion
Secondary	All-cause mortality	All-cause mortality will be obtained during a two-year follow-up from hospital records and/or the Swedish death registry	Within 2 years from study inclusion
Secondary	Cancer progression among enrolled patients with a cancer diagnosis at study inclusion	Patients with cancer progression will be identified during a two-year follow-up from hospital records and/or the Swedish cancer registry	Within 2 years from study inclusion