Venous ThromboembolismVENETIANCT03646409
Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer
An observational study of Venous Thromboembolism and Esophagus Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
Trial summary
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Esophagus Cancer, Bleeding
- What is being tested?
- Venous thromboembolic event, arterial thromboembolic event, bleeding events
- How many people
- 542 participants
- Where
- 1 siteNetherlands
- Study dates
- 11 Jun 2018to 1 Dec 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with esophageal cancer, receiving chemotherapy.
Who may be able to join
- Esophageal cancer patients
- Receiving chemotherapy
- Age at least 18 years old
Who cannot join
- Death <3 months after cancer diagnosis (baseline)
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
Read the detailed description
Patients with cancer are at high risk of venous thromboembolism (VTE), including deep-vein thrombosis and pulmonary embolism. For cancer patients receiving chemotherapy the incidence of VTE is even higher.
Several predictive models were previously developed to identify and justify thromboprophylaxis for cancer patietns who are at highest risk of VTE, like the Khorana and PROTECHT score. The Khorana score is a risk-stratification tool to select patients at high risk of VTE for thromboprophylaxis. The PROTECHT score takes cisplatin-based chemotherapy into account in addition of the Khorana score.
Thereby, the incidence of bleeding and VTE in patients with esophageal cancer is not clear.
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
- Being tested
- Venous thromboembolic event, arterial thromboembolic event, bleeding events
- Medical subject headings
- Venous Thromboembolism, Esophageal Neoplasms, Hemorrhage
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous thromboembolic event, arterial thromboembolic event, bleeding eventsOther
Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Patients with esophageal cancer receiving chemotherapy | Patients > 18 years with esophageal cancer receiving neoadjuvant chemotherapy Receives: Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events |
What is being measured
The primary outcome is the main question the study is designed to answer.
VTE- and bleeding incidence
6- and 12-month VTE- and bleeding incidence
Measured: from start of cancer diagnosis
Secondary outcomes (3)
Predictive performance of VTE risk factors and known prediction models
To assess the predictive value of Khorana, modified Vienna-, and PROTECHT score in Predictive performance of VTE risk factors and known prediction models
Measured: from start cancer diagnosis
Predictive performance of bleeding risk factors and known prediction models
Predictive performance of bleeding risk factors and known prediction models
Measured: from start cancer diagnosis
Arterial thromboembolism (ATE) incidence
6- and 12-month ATE incidence
Measured: from start of cancer diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2018
- Study start11 Jun 2018
- Primary completion1 Oct 2018
- Study completion1 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- More trials run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)The 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
- Retrospective
- Enrolment
- 542 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
- Investigators
- Harry R Büller, Prof. dr., Principal investigator, Vascular Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03646409
- Sponsor's protocol ID
- thromboembolism and bleeding
- Acronym
- VENETIA
- Status last verified
- Jan 2020
- First submitted
- 23 Aug 2018
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Timp JF, Braekkan SK, Versteeg HH, Cannegieter SC. Epidemiology of cancer-associated venous thrombosis. Blood. 2013 Sep 5;122(10):1712-23. doi: 10.1182/blood-2013-04-460121. Epub 2013 Aug 1.
PubMed 23908465Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients. Cancer. 2007 Nov 15;110(10):2339-46. doi: 10.1002/cncr.23062.
PubMed 17918266Starling N, Rao S, Cunningham D, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR. Thromboembolism in patients with advanced gastroesophageal cancer treated with anthracycline, platinum, and fluoropyrimidine combination chemotherapy: a report from the UK National Cancer Research Institute Upper Gastrointestinal Clinical Studies Group. J Clin Oncol. 2009 Aug 10;27(23):3786-93. doi: 10.1200/JCO.2008.19.4274. Epub 2009 Apr 27.
PubMed 19398575Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.
PubMed 18216292Pabinger I, Thaler J, Ay C. Biomarkers for prediction of venous thromboembolism in cancer. Blood. 2013 Sep 19;122(12):2011-8. doi: 10.1182/blood-2013-04-460147. Epub 2013 Aug 1.
PubMed 23908470Verso M, Agnelli G, Barni S, Gasparini G, LaBianca R. A modified Khorana risk assessment score for venous thromboembolism in cancer patients receiving chemotherapy: the Protecht score. Intern Emerg Med. 2012 Jun;7(3):291-2. doi: 10.1007/s11739-012-0784-y. Epub 2012 May 1. No abstract available.
PubMed 22547369
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer
- ClinicalTrials.gov ID
- NCT03646409
- Acronym / sponsor ID
- VENETIA / thromboembolism and bleeding
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 542 participants (actual)
- Lead sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)University, hospital or other
- Study start
- 11 Jun 2018 (actual)
- Primary completion
- 1 Oct 2018 (actual)
- Study completion
- 1 Dec 2018 (actual)
- First posted
- 24 Aug 2018 (actual)
- 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.
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
Detailed description
Patients with cancer are at high risk of venous thromboembolism (VTE), including deep-vein thrombosis and pulmonary embolism. For cancer patients receiving chemotherapy the incidence of VTE is even higher.
Several predictive models were previously developed to identify and justify thromboprophylaxis for cancer patietns who are at highest risk of VTE, like the Khorana and PROTECHT score. The Khorana score is a risk-stratification tool to select patients at high risk of VTE for thromboprophylaxis. The PROTECHT score takes cisplatin-based chemotherapy into account in addition of the Khorana score.
Thereby, the incidence of bleeding and VTE in patients with esophageal cancer is not clear.
This study aims to assess the 6- and 12-month venous thromboembolism (VTE) and bleeding incidence from the start of cancer diagnosis in a retrospective cohort of patients with esophageal cancer. Additionally, the predictive value of the Khorana score and several other VTE and bleeding prediction scores and risk factors will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with esophageal cancer receiving chemotherapy | – | Other: Venous thromboembolic event, arterial thromboembolic event, bleeding eventsPatients > 18 years with esophageal cancer receiving neoadjuvant chemotherapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with esophageal cancer, receiving chemotherapy.
Key inclusion criteria (3 listed)
- Esophageal cancer patients
- Receiving chemotherapy
- Age at least 18 years old
Key exclusion criteria (1 listed)
- Death <3 months after cancer diagnosis (baseline)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Venous thromboembolic event, arterial thromboembolic event, bleeding eventsWhether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy | Other | Patients with esophageal cancer receiving chemotherapy |
Primary outcome
VTE- and bleeding incidence
Time frame: from start of cancer diagnosis
6- and 12-month VTE- and bleeding incidence
3 secondary outcomes
Predictive performance of VTE risk factors and known prediction models
Time frame: from start cancer diagnosis
Predictive performance of bleeding risk factors and known prediction models
Time frame: from start cancer diagnosis
Arterial thromboembolism (ATE) incidence
Time frame: from start of cancer diagnosis
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 13 Jan 2020.
- Background: PubMed 23908465Timp JF, Braekkan SK, Versteeg HH, Cannegieter SC. Epidemiology of cancer-associated venous thrombosis. Blood. 2013 Sep 5;122(10):1712-23. doi: 10.1182/blood-2013-04-460121. Epub 2013 Aug 1.
- Background: PubMed 17918266Khorana AA, Francis CW, Culakova E, Kuderer NM, Lyman GH. Frequency, risk factors, and trends for venous thromboembolism among hospitalized cancer patients. Cancer. 2007 Nov 15;110(10):2339-46. doi: 10.1002/cncr.23062.
- Background: PubMed 19398575Starling N, Rao S, Cunningham D, Iveson T, Nicolson M, Coxon F, Middleton G, Daniel F, Oates J, Norman AR. Thromboembolism in patients with advanced gastroesophageal cancer treated with anthracycline, platinum, and fluoropyrimidine combination chemotherapy: a report from the UK National Cancer Research Institute Upper Gastrointestinal Clinical Studies Group. J Clin Oncol. 2009 Aug 10;27(23):3786-93. doi: 10.1200/JCO.2008.19.4274. Epub 2009 Apr 27.
- Background: PubMed 18216292Khorana AA, Kuderer NM, Culakova E, Lyman GH, Francis CW. Development and validation of a predictive model for chemotherapy-associated thrombosis. Blood. 2008 May 15;111(10):4902-7. doi: 10.1182/blood-2007-10-116327. Epub 2008 Jan 23.
- Background: PubMed 23908470Pabinger I, Thaler J, Ay C. Biomarkers for prediction of venous thromboembolism in cancer. Blood. 2013 Sep 19;122(12):2011-8. doi: 10.1182/blood-2013-04-460147. Epub 2013 Aug 1.
- Background: PubMed 22547369Verso M, Agnelli G, Barni S, Gasparini G, LaBianca R. A modified Khorana risk assessment score for venous thromboembolism in cancer patients receiving chemotherapy: the Protecht score. Intern Emerg Med. 2012 Jun;7(3):291-2. doi: 10.1007/s11739-012-0784-y. Epub 2012 May 1. No abstract available.
- Individual participant dataSharing planned: No
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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.
Harry R Büller, Prof. dr. principal investigator
Vascular Medicine
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 Esophagus Cancer, run by Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA) at 1 site in Netherlands.
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 3 inclusion and 1 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 13 Jan 2020. 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 Netherlands. 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.
What does the primary outcome measure?
VTE- and bleeding incidence (time frame: from start of cancer diagnosis). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03646409, which also lists 6 linked publications.
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 13 Jan 2020.