Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Completed

• Conditions: Esophagus Cancer; Bleeding; Chemotherapy Effect; Venous Thromboembolism
• Interventions: Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events

• Registration Number: NCT03646409
• Lead Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Brief 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. 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 Timeline

• Study Start: 2018-06-11
• Study First Submitted: 2018-08-23
• Study First Submitted QC: 2018-08-23
• Study First Posted: 2018-08-24
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-08
• Last Update Posted: 2020-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

• Esophageal cancer patients
• Receiving chemotherapy
• Age at least 18 years old

Exclusion Criteria

• Death <3 months after cancer diagnosis (baseline)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with esophageal cancer receiving chemotherapy	Venous thromboembolic event, arterial thromboembolic event, bleeding events	Patients \> 18 years with esophageal cancer receiving neoadjuvant chemotherapy

Primary Outcome Measures

Name	Time	Method
VTE- and bleeding incidence	from start of cancer diagnosis	6- and 12-month VTE- and bleeding incidence

Secondary Outcome Measures

Name	Time	Method
Predictive performance of VTE risk factors and known prediction models	from start cancer diagnosis	To assess the predictive value of Khorana, modified Vienna-, and PROTECHT score in Predictive performance of VTE risk factors and known prediction models
Predictive performance of bleeding risk factors and known prediction models	from start cancer diagnosis	Predictive performance of bleeding risk factors and known prediction models
Arterial thromboembolism (ATE) incidence	from start of cancer diagnosis	6- and 12-month ATE incidence

Trial Locations

Locations (1)

Amsterdam UMC; 🇳🇱 Amsterdam, Netherlands