ThrombosisGIVTENCT00660205
Venous Thromboembolism and Haemostatic Disturbances in Patients With Upper Gastrointestinal Cancer
An observational study of Thrombosis and Deep Venous Thrombosis, run by University of Aarhus at 1 site in Denmark.
Trial summary
Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). Today we know that patients with adenocarcinomas of the gastro intestinal tract (GI-tract) often is in a hypercoagulable state. Read more about this study
- Who is it for?
- Ages 15 to 85 years
- Conditions the study is for
- Thrombosis, Deep Venous Thrombosis, Pulmonary Embolism
- How many people
- 285 participants
- Where
- 1 siteDenmark
- Study dates
- Feb 2008to Feb 2011
- 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 15 to 85 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: From February 2008 to December 2009 all patients admitted to The Department of Surgical Gastroenterology with upper GI cancer or pancreatic cancer will be included. Depending on the disease nature and progression, the patients will be followed as palliation or surgery cohorts.
Who may be able to join
- Clinical diagnosis of upper gastro intestinal cancer.
Who cannot join
- Earlier (within prev. 3 years) or concomitant cancer disease of any origin.
- Known immunological connective tissue disease.
- Mental disorder.
- Treatment with heparin, low molecular weight heparin or K-vitamin antagonist at the time of inclusion.
- Consent not attained.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Surgical Gastroenterology, Aalborg Hospital
Aalborg, Region North, 9100
About this study
Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). Today we know that patients with adenocarcinomas of the gastro intestinal tract (GI-tract) often is in a hypercoagulable state.
In our observational study we collect patients admitted to department with a tentative diagnosis of upper GI cancer including pancreas cancer and offer them flow doppler ultrasounds of both legs for diagnosis of DVT in the entire treatment time. The routine CT-scan of the chest is modified to diagnose PE. This will be compared with blood samples analysed for coagulation markers including D-dimer - a fibrinogen degradation product.
Read the detailed description
Armand Troussau observed back in 1865 a particular condition of the blood that predisposes to spontaneous coagulation in patients with gastric cancer. Today it is known that adenocarcinomas in the gastrointestinal (GI) tract including tumours of colon and rectum is accompanied by an hypercoagulable state.
Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). In fact PE in cancer patients is the second most common cause of death.
In an analysis of 13 cohort studies published with observational data Otten and Prins concludes that the prevalence of VTE in cancer patients varied between 10 and 20%. Variation could be explained with inconsistency. Patients suffering from thrombosis secondary to hemi paresis and paraplegia were included. Patients where included at time of VTE and not at time of cancer diagnosis.
Levitan et al looked at discharge diagnosis in 1211944 cancer patients and found among gastric cancer patients a frequency of VTE at 85 per 10000 patients and in pancreatic cancer 110 per 10000. Gastric cancer patients had a relative risk of 1.49 compared to non-cancer patients and pancreatic cancer patients a relative risk of 2.05 compared to non-cancer patients. This put pancreatic cancer among the most prone malignancy to cause thromboembolic complications. In a newly published study of 202 pancreatic cancer patients 19 developed venous thrombosis resulting in a 58 fold increased risk compared to general population with an incidence of 108/1000 patient-years and cumulative incidence after 6 months of 74/1000. 15 out of 19 cases of VTE occurred in the first 6 months since diagnosis of cancer. Tumours located in the corpus or cauda had twice the risk of caput. Chemotherapy resulted in a 4.8 fold risk of venous thrombosis.
Postoperatively VTE is higher in cancer patients than in non-cancer patients after surgery. A multicenter study including Danish patients - using phlebography - has shown VTE in 23% of patients after surgery for colorectal cancer. Coagulation activity - as assessed by sensitive biochemical markers - was related to tumour load.
Stender et al has in a newly published study shown a high preoperative prevalence of DVT in 193 colorectal cancer patients with a prevalence of 16% in women and 2.6% in men. In another newly published study asymptomatic DVT is found ovarian cancer patients with elevated levels of D-Dimer before treatment. The mechanism by which cancer induce VTE is at present subject to great interest.
Plasma D-dimer (DD), a degradation product of cross-linked fibrin, is routinely used to support or exclude the tentative diagnosis of DVT, combined with clinical assessment and ultrasonography (US).
The accuracy of DD assays in cancer patients is unknown, despite their high negative predictive values (NPV) in non cancer patients. A negative DD seems to exclude PE in cancer patients, but DD in combination imaging techniques such as US or computed tomography (CT) seems to improve diagnostic work-up but needs further investigation.
- Conditions
- Thrombosis, Deep Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism, Pancreas Cancer, Esophagus Cancer
- Keywords
- DVT, PE, D-dimer, cancer, VTE
- Medical subject headings
- Thrombosis, Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism, Pancreatic Neoplasms, Esophageal Neoplasms, Stomach Neoplasms, Neoplasms
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 |
|---|---|---|
| operation | Patients with upper gastro intestinal cancer who underwent surgery | |
| palliation | Patients with upper gastro intestinal cancer who did not underwent surgery | |
| control | Persons with no cancer who accepted to be control with blood samples and flow doppler ultrasound examination of both legs. |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThrombosisStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- 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
- 285 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ole Thorlacius-Ussing, Professor, DMSC, MD, Principal investigator, Aalborg Hospital department of Aarhus University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00660205
- Sponsor's protocol ID
- N-20080002
- Acronym
- GIVTE
- Status last verified
- Mar 2012
- First submitted
- 10 Apr 2008
- Last updated
- 26 Mar 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism and Haemostatic Disturbances in Patients With Upper Gastrointestinal Cancer
- ClinicalTrials.gov ID
- NCT00660205
- Acronym / sponsor ID
- GIVTE / N-20080002
- Conditions
- Thrombosis, Deep Venous Thrombosis, Pulmonary Embolism, Venous Thromboembolism, Pancreas Cancer, Esophagus Cancer
- Keywords
- DVT, PE, D-dimer, cancer, VTE
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 285 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 17 Apr 2008 (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.
Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). Today we know that patients with adenocarcinomas of the gastro intestinal tract (GI-tract) often is in a hypercoagulable state.
In our observational study we collect patients admitted to department with a tentative diagnosis of upper GI cancer including pancreas cancer and offer them flow doppler ultrasounds of both legs for diagnosis of DVT in the entire treatment time. The routine CT-scan of the chest is modified to diagnose PE. This will be compared with blood samples analysed for coagulation markers including D-dimer - a fibrinogen degradation product.
Detailed description
Armand Troussau observed back in 1865 a particular condition of the blood that predisposes to spontaneous coagulation in patients with gastric cancer. Today it is known that adenocarcinomas in the gastrointestinal (GI) tract including tumours of colon and rectum is accompanied by an hypercoagulable state.
Cancer is a well known risk factor for venous thromboembolism (VTE) such as deep venous thrombosis (DVT) and pulmonary embolism (PE). In fact PE in cancer patients is the second most common cause of death.
In an analysis of 13 cohort studies published with observational data Otten and Prins concludes that the prevalence of VTE in cancer patients varied between 10 and 20%. Variation could be explained with inconsistency. Patients suffering from thrombosis secondary to hemi paresis and paraplegia were included. Patients where included at time of VTE and not at time of cancer diagnosis.
Levitan et al looked at discharge diagnosis in 1211944 cancer patients and found among gastric cancer patients a frequency of VTE at 85 per 10000 patients and in pancreatic cancer 110 per 10000. Gastric cancer patients had a relative risk of 1.49 compared to non-cancer patients and pancreatic cancer patients a relative risk of 2.05 compared to non-cancer patients. This put pancreatic cancer among the most prone malignancy to cause thromboembolic complications. In a newly published study of 202 pancreatic cancer patients 19 developed venous thrombosis resulting in a 58 fold increased risk compared to general population with an incidence of 108/1000 patient-years and cumulative incidence after 6 months of 74/1000. 15 out of 19 cases of VTE occurred in the first 6 months since diagnosis of cancer. Tumours located in the corpus or cauda had twice the risk of caput. Chemotherapy resulted in a 4.8 fold risk of venous thrombosis.
Postoperatively VTE is higher in cancer patients than in non-cancer patients after surgery. A multicenter study including Danish patients - using phlebography - has shown VTE in 23% of patients after surgery for colorectal cancer. Coagulation activity - as assessed by sensitive biochemical markers - was related to tumour load.
Stender et al has in a newly published study shown a high preoperative prevalence of DVT in 193 colorectal cancer patients with a prevalence of 16% in women and 2.6% in men. In another newly published study asymptomatic DVT is found ovarian cancer patients with elevated levels of D-Dimer before treatment. The mechanism by which cancer induce VTE is at present subject to great interest.
Plasma D-dimer (DD), a degradation product of cross-linked fibrin, is routinely used to support or exclude the tentative diagnosis of DVT, combined with clinical assessment and ultrasonography (US).
The accuracy of DD assays in cancer patients is unknown, despite their high negative predictive values (NPV) in non cancer patients. A negative DD seems to exclude PE in cancer patients, but DD in combination imaging techniques such as US or computed tomography (CT) seems to improve diagnostic work-up but needs further investigation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| operation | – | –Patients with upper gastro intestinal cancer who underwent surgery |
| palliation | – | –Patients with upper gastro intestinal cancer who did not underwent surgery |
| control | – | –Persons with no cancer who accepted to be control with blood samples and flow doppler ultrasound examination of both legs. |
Who may qualify
- Ages
- 15 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- From February 2008 to December 2009 all patients admitted to The Department of Surgical Gastroenterology with upper GI cancer or pancreatic cancer will be included. Depending on the disease nature and progression, the patients will be followed as palliation or surgery cohorts.
Key inclusion criteria (1 listed)
- Clinical diagnosis of upper gastro intestinal cancer.
Key exclusion criteria (5 listed)
- Earlier (within prev. 3 years) or concomitant cancer disease of any origin.
- Known immunological connective tissue disease.
- Mental disorder.
- Treatment with heparin, low molecular weight heparin or K-vitamin antagonist at the time of inclusion.
- Consent not attained.
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
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Mar 2012.
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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, Professor, DMSC, MD principal investigator
Aalborg Hospital department of Aarhus 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 Thrombosis and Deep Venous Thrombosis, run by University of Aarhus 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 5 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: finished, as of the sponsor's last update on 26 Mar 2012. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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.
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 26 Mar 2012.