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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with esophageal cancer receiving chemotherapy | Patients > 18 years with esophageal cancer receiving neoadjuvant chemotherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Venous thromboembolic event, arterial thromboembolic event, bleeding events | Other | Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| VTE- and bleeding incidence | 6- and 12-month VTE- and bleeding incidence | from start of cancer diagnosis |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | from start cancer diagnosis |
| Predictive performance of bleeding risk factors and known prediction models |
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Inclusion Criteria:
Exclusion Criteria:
- Death <3 months after cancer diagnosis (baseline)
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Patients with esophageal cancer, receiving chemotherapy.
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| Name | Affiliation | Role |
|---|---|---|
| Harry R Büller, Prof. dr. | Vascular Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Amsterdam UMC | Amsterdam | 1105 AZ | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23908465 | Background | 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. | |
| 17918266 | Background | Khorana 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. |
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Predictive performance of bleeding risk factors and known prediction models |
| from start cancer diagnosis |
| Arterial thromboembolism (ATE) incidence | 6- and 12-month ATE incidence | from start of cancer diagnosis |
| 19398575 | Background | Starling 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. |
| 18216292 | Background | Khorana 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. |
| 23908470 | Background | Pabinger 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. |
| 22547369 | Background | Verso 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. |
| ID | Term |
|---|---|
| D054556 | Venous Thromboembolism |
| D004938 | Esophageal Neoplasms |
| D006470 | Hemorrhage |
| ID | Term |
|---|---|
| D013923 | Thromboembolism |
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006258 | Head and Neck Neoplasms |
| D004066 | Digestive System Diseases |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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