Venous ThromboembolismNCT02480790
Venous Thromboembolic Complications in Ovarian Cancer
An observational study of Venous Thromboembolism and Ovarian Neoplasms, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site in Denmark.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 100 years, women only
- Conditions the study is for
- Venous Thromboembolism, Ovarian Neoplasms, Ovarian Cancer
- How many people
- 98 participants
- Where
- 1 siteDenmark
- Study dates
- Nov 2014to Sep 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Gynecology and Obstetrics, Aalborg University Hospital
Aalborg, 9000
About this study
Official title: 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.
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:
- 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.
- Conditions
- Venous Thromboembolism, Ovarian Neoplasms, Ovarian Cancer, Deep Vein Thrombosis, Lung Embolism
- Medical subject headings
- Venous Thromboembolism, Ovarian Neoplasms, Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Venous thromboembolism due to ovarian cancer
Compressive ultrasound scan of lower extremities and pulmonary CT-angiography
Measured: one year
Secondary outcomes (2)
Changes in the coagulation system in case of ovarian cancer
Analysis of blood samples
Measured: 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
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2015 (estimated)
- Study startNov 2014
- Primary completionMay 2017
- Study completionSep 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery, Aalborg University Hospital
- Investigators
- Ole Thorlacius-Ussing, MD, DMSc, Principal investigator, Department of Gastrointestinal Surgery, Aalborg University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02480790
- Sponsor's protocol ID
- OV-VTE
- Status last verified
- Oct 2018
- First submitted
- 30 May 2015
- Last updated
- 5 Oct 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 5 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolic Complications in Patients With Ovarian Cancer Compared to Patients With Benign Ovarian Tumours
- ClinicalTrials.gov ID
- NCT02480790
- Acronym / sponsor ID
- OV-VTE
- Conditions
- Venous Thromboembolism, Ovarian Neoplasms, Ovarian Cancer, Deep Vein Thrombosis, Lung Embolism
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Ole Thorlacius-Ussing, MD, DMSc, Professor of SurgeryUniversity, hospital or other
- Study start
- Nov 2014 (actual)
- Primary completion
- May 2017 (actual)
- Study completion
- Sep 2019 (estimated)
- First posted
- 25 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Venous thromboembolism due to ovarian cancer
Time frame: one year
Compressive ultrasound scan of lower extremities and pulmonary CT-angiography
2 secondary outcomes
Changes in the coagulation system in case of ovarian cancer
Time frame: one year
Impact of changes in the coagulation system on disease prognosis in ovarian cancer
Time frame: one year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Oct 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ole Thorlacius-Ussing, MD, DMSc principal investigator
Department of Gastrointestinal Surgery, Aalborg University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Ovarian Neoplasms, run by Ole Thorlacius-Ussing, MD, DMSc, Professor of Surgery at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Venous thromboembolism due to ovarian cancer (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Oct 2018.