Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Conditions
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Venous Thromboembolism, Esophagus Cancer, Bleeding, Chemotherapy Effect

Intervention / Treatment
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* Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Esophageal cancer patients Receiving chemotherapy Age at least 18 years old Exclusion Criteria: - Death <3 months after cancer diagnosis (baseline)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with esophageal cancer receiving chemotherapy<br>Patients > 18 years with esophageal cancer receiving neoadjuvant chemotherapy | Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events<br>* Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VTE- and bleeding incidence | 6- and 12-month VTE- and bleeding incidence | from start of cancer diagnosis | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |