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NCT Number: NCT03646409

Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

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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Key information

Conditions

Venous Thromboembolism Bleeding Cardiovascular Diseases Chemotherapy Effect Digestive System Diseases Digestive System Neoplasms Embolism and Thrombosis Esophageal Diseases Esophageal Neoplasms Esophagus Cancer Gastrointestinal Diseases Gastrointestinal Neoplasms Head and Neck Neoplasms Hemorrhage Neoplasms Neoplasms by Site Pathologic Processes Pathological Conditions, Signs and Symptoms Thromboembolism Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • Death <3 months after cancer diagnosis (baseline)

Treatment and study plan

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

Primary outcomes

  1. VTE- and bleeding incidence

    Time frame: from start of cancer diagnosis

    6- and 12-month VTE- and bleeding incidence

Secondary outcomes

  1. Predictive performance of VTE risk factors and known prediction models

    Time frame: 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

  2. Predictive performance of bleeding risk factors and known prediction models

    Time frame: from start cancer diagnosis

    Predictive performance of bleeding risk factors and known prediction models

  3. Arterial thromboembolism (ATE) incidence

    Time frame: from start of cancer diagnosis

    6- and 12-month ATE incidence

Sponsors and collaborators

Lead sponsor

Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Other

Registry information

Acronym: VENETIA

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Aug 24, 2018
Registry last updated
Jan 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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