NCT03781531

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Mar 2017

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress78%
Mar 2017Dec 2028

Study Start

First participant enrolled

March 1, 2017

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

December 17, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 20, 2018

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2022

Completed
6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Expected
Last Updated

December 20, 2018

Status Verified

December 1, 2018

Enrollment Period

5.8 years

First QC Date

December 17, 2018

Last Update Submit

December 18, 2018

Conditions

CancerVenous Thromboembolism

Keywords

Occult cancerVenous thromboembolismBiomarkersEarly diagnosisNeutrophil extracellular traps

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Recurrent thrombotic event

    Within 2 years from study inclusion

  • All-cause mortality

    Within 2 years from study inclusion

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

    Within 2 years from study inclusion

Study Arms (1)

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • 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

You may not qualify if:

  • \> 2 days after VTE diagnosis;
  • No blood withdrawal at baseline

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Danderyd Hospital

Stockholm, 18350, Sweden

RECRUITING

Södersjukhuset

Stockholm, Sweden

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

NeoplasmsVenous ThromboembolismDisease

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Charlotte Thålin, M.D., Ph.D.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

  • Håkan Wallén, M.D., Prof.

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Charlotte Thålin, M.D., Ph.D.

CONTACT

+46709565120charlotte.thalin@sll.se

Håkan Wallén, M.D., Prof.

CONTACT

+46707374935hakan.wallen@ki.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 17, 2018

First Posted

December 20, 2018

Study Start

March 1, 2017

Primary Completion

December 31, 2022

Study Completion (Estimated)

December 31, 2028

Last Updated

December 20, 2018

Record last verified: 2018-12

Locations

SE(2)