CClinicalTrials.gg
Status unknownNCT02480790Updated Oct 5, 2018

Venous Thromboembolic Complications in Ovarian Cancer

An observational study in Venous Thromboembolism, Ovarian Neoplasms and Ovarian Cancer, sponsored by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery. Status unknown at 1 site in Denmark. Open to female participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2018-10-05.

Sponsored by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery · Observational

The sponsor has not verified this record recently (last verified Oct 2018), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
98
Ages
18 Years to 100 Years
Sex
Female
01

Study 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.

Read the detailed description

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.
02

Conditions studied

  • Venous Thromboembolism
  • Ovarian Neoplasms
  • Ovarian Cancer
  • Deep Vein Thrombosis
  • Lung Embolism
03

In context

Ovarian Neoplasms

2,695 studies on the registry are indexed under Ovarian Neoplasms; 727 are open to participants now.

This study's enrollment of 98 is below the median of 200 across 527 observational studies indexed under Ovarian Neoplasms.

Browse Ovarian Neoplasms studies →

Lead sponsor

Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery is the lead sponsor of 7 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
Female
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

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.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
98 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. Venous thromboembolism due to ovarian cancer

    Compressive ultrasound scan of lower extremities and pulmonary CT-angiography

    Time frame: one year

Secondary outcomes

  1. Changes in the coagulation system in case of ovarian cancer

    Analysis of blood samples

    Time frame: one year

  2. 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

07

Study locations

1 site
  • Department of Gynecology and Obstetrics, Aalborg University Hospital
    Aalborg, 9000, Denmark
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 5, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02480790
Lead sponsor
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
Responsible party
Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery (Professor, Aalborg University Hospital) — Sponsor-investigator
First posted
Jun 25, 2015
Start date
Nov 2014
Primary completion
May 2017
Completion
Sep 2019 (estimated)
Last update
Oct 5, 2018

Study contacts

Ole Thorlacius-Ussing, MD, DMSc
principal investigator · Department of Gastrointestinal Surgery, Aalborg University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion