Venous Thromboembolic Complications in Ovarian Cancer
Venous Thromboembolic Complications in Patients With Ovarian Cancer Compared to Patients With Benign Ovarian Tumours
調査の概要
詳細な説明
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.
The objectives of the study are:
- In a prospective study at Aalborg University Hospital to estimate the incidence of clinical and subclinical venous thromboembolism (VTE) in patients with suspected ovarian cancer before and after initiation of treatment. The impact of VTE on survival will be evaluated.
- In the same prospective cohort the correlation between markers of coagulation and fibrinolysis and subclinical VTE, tumour burden and overall survival will be evaluated.
- Evaluate the correlation between immunohistochemical demonstrated tissue factor (TF) in tumour tissue and circulating TF in peripheral blood and the relation to VTE and tumour burden.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Aalborg、デンマーク、9000
- Department of Gynecology and Obstetrics, Aalborg University Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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:
- 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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
コホートと介入
グループ/コホート |
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Patients with malignant disease
Patients with ovarian, tubar or primary peritoneal cancer
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Patients with benign disease
Patients with suspected ovarian cancer where the final pathologic diagnosis is benign
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この研究は何を測定していますか?
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Venous thromboembolism due to ovarian cancer
時間枠:one year
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Compressive ultrasound scan of lower extremities and pulmonary CT-angiography
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one year
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in the coagulation system in case of ovarian cancer
時間枠:one year
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Analysis of blood samples
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one year
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Impact of changes in the coagulation system on disease prognosis in ovarian cancer
時間枠:one year
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Evaluation of classic and novel coagulation markers and their relation to prognosis
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one year
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協力者と研究者
捜査官
- 主任研究者:Ole Thorlacius-Ussing, MD, DMSc、Department of Gastrointestinal Surgery, Aalborg University Hospital
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
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