Denna sida har översatts automatiskt och översättningens korrekthet kan inte garanteras. Vänligen se engelsk version för en källtext.

Venous Thromboembolic Complications in Ovarian Cancer

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

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.

Studieöversikt

Detaljerad beskrivning

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:

  1. 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.
  2. In the same prospective cohort the correlation between markers of coagulation and fibrinolysis and subclinical VTE, tumour burden and overall survival will be evaluated.
  3. 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.

Studietyp

Observationell

Inskrivning (Faktisk)

98

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

      • Aalborg, Danmark, 9000
        • Department of Gynecology and Obstetrics, Aalborg University Hospital

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

18 år till 100 år (Vuxen, Äldre vuxen)

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Kvinna

Testmetod

Icke-sannolikhetsprov

Studera befolkning

Women referred to the outpatient clinic with suspected ovarian cancer, where the initial examinations with ultrasound scan and measurement of ca-125 in blood reveal a Risk Malignancy Index (RMI) ≥ 200 indicating a high risk of ovarian cancer.

Beskrivning

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.

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Patients with malignant disease
Patients with ovarian, tubar or primary peritoneal cancer
Patients with benign disease
Patients with suspected ovarian cancer where the final pathologic diagnosis is benign

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Venous thromboembolism due to ovarian cancer
Tidsram: one year
Compressive ultrasound scan of lower extremities and pulmonary CT-angiography
one year

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
Changes in the coagulation system in case of ovarian cancer
Tidsram: one year
Analysis of blood samples
one year
Impact of changes in the coagulation system on disease prognosis in ovarian cancer
Tidsram: one year
Evaluation of classic and novel coagulation markers and their relation to prognosis
one year

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Utredare

  • Huvudutredare: Ole Thorlacius-Ussing, MD, DMSc, Department of Gastrointestinal Surgery, Aalborg University Hospital

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 november 2014

Primärt slutförande (Faktisk)

1 maj 2017

Avslutad studie (Förväntat)

1 september 2019

Studieregistreringsdatum

Först inskickad

30 maj 2015

Först inskickad som uppfyllde QC-kriterierna

22 juni 2015

Första postat (Uppskatta)

25 juni 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

5 oktober 2018

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

4 oktober 2018

Senast verifierad

1 oktober 2018

Mer information

Denna information hämtades direkt från webbplatsen clinicaltrials.gov utan några ändringar. Om du har några önskemål om att ändra, ta bort eller uppdatera dina studieuppgifter, vänligen kontakta register@clinicaltrials.gov. Så snart en ändring har implementerats på clinicaltrials.gov, kommer denna att uppdateras automatiskt även på vår webbplats .

Kliniska prövningar på Ovariella neoplasmer

3
Prenumerera