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临床试验/NCT02480790
NCT02480790Unknown不适用

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

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery1 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2014年11月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
98
试验地点
1
主要终点
Venous thromboembolism due to ovarian cancer

研究概览

简要总结

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.

详细描述

Venous thromboembolism (VTE) is a common complication after surgery. Deep-vein thrombosis (DVT) and pulmonary embolism (PE) constitute VTE. PE is often a consequence of DVT and it is a feared complication and the most common preventable cause of hospital death. VTE can be asymptomatic and can be detected by a compression ultrasound scan (CUS) of the legs and a Computer Tomography (CT) of the lungs. It is wellknown that cancer patients are at higher risk of developing VTE, the risk is approximately seven times higher than in the background population. A Danish study showed a significantly higher risk of death when VTE was diagnosed at the same time as the cancer diagnosis with a 12 % one year survival compared to 36 % in cancer patients without a history of VTE.

Approximately 600 women in Denmark are diagnosed with ovarian cancer every year and it is the forth most common cause of cancer death among Danish women. Earlier studies have found that up to 31 % of ovarian cancer women develop VTE as a consequence of the disease and/or the treatment. Very few studies have examined the incidence of VTE before treatment.

Methods: A Pulmonary CT-angiography is included in the routinely performed Fluorodeoxyglucose Positron Emission Tomography - Computer Tomography (FDG PET-CT) to reveal pulmonary embolism at time of first referral. Compressive ultrasound scan including Doppler flow of the lower extremities is performed four times from first referral and during a one-year follow up period to detect clinical or subclinical deep vein thrombosis (DVT) before and after initiation of treatment.

Blood and tissue samples are taken, prepared and stored at -80 degrees in the Danish Cancer-Biobank for later analyzes of coagulation markers.

Immune histochemical techniques will be use to demonstrate tissue factor (TF) in tumor tissue.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

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

结局指标

主要结局

Venous thromboembolism due to ovarian cancer

时间窗: one year

Compressive ultrasound scan of lower extremities and pulmonary CT-angiography

次要结局

  • Changes in the coagulation system in case of ovarian cancer(one year)
  • Impact of changes in the coagulation system on disease prognosis in ovarian cancer(one year)

研究者

发起方
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

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

Professor

Aalborg University Hospital

研究点 (1)

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Venous Thromboembolic Complications in Ovarian Cancer | 临床试验