Venous Thromboembolic Complications in Ovarian Cancer

NCT02480790UNKNOWNOBSERVATIONAL

Summary

Objectives of the study are: To estimate the incidence of venous thromboembolism (VTE) in a cohort of women with suspected ovarian cancer and evaluate changes in the coagulation system in case of benign or malignant disease. The impact of changes in the coagulation system on disease prognosis will be evaluated.

Key Facts

Lead Sponsor

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery

Enrollment

98

Start Date

2014-11-01

Completion Date

2017-05-01

Study Type

OBSERVATIONAL

Official Title

Venous Thromboembolic Complications in Patients With Ovarian Cancer Compared to Patients With Benign Ovarian Tumours

Conditions

Venous ThromboembolismOvarian NeoplasmsOvarian CancerDeep Vein ThrombosisLung Embolism

Eligibility

Age Range

18 Years – 100 Years

Sex

FEMALE

Inclusion Criteria:

Women referred to the Department of Gynaecology and Obstetrics, Aalborg University Hospital on suspicion of ovarian cancer can be included if they present with a RMI ≥ 200.

Exclusion Criteria:

1. Previous cancer (within previous 3 years) or concomitant cancer of any origin.
2. Known immunological connective tissue disease.
3. Treatment with heparin, low molecular weight heparin (LMWH) or vitamin K antagonist at the time of inclusion.
4. Lack of informed consent.

Outcome Measures

Primary Outcomes

Venous thromboembolism due to ovarian cancer

Compressive ultrasound scan of lower extremities and pulmonary CT-angiography

Time frame: one year

Secondary Outcomes

Changes in the coagulation system in case of ovarian cancer

Analysis of blood samples

Time frame: one year

Impact of changes in the coagulation system on disease prognosis in ovarian cancer

Evaluation of classic and novel coagulation markers and their relation to prognosis

Time frame: one year

Locations

Department of Gynecology and Obstetrics, Aalborg University Hospital, Aalborg, Denmark

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Venous Thromboembolic Complications in Ovarian Cancer