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Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03646409
Acronym
VENETIA
Enrollment
542
Registered
2018-08-24
Start date
2018-06-11
Completion date
2018-12-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding, Chemotherapy Effect, Esophagus Cancer, Venous Thromboembolism

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.

Interventions

OTHERVenous thromboembolic event, arterial thromboembolic event, bleeding events

Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

\- Death \<3 months after cancer diagnosis (baseline)

Design outcomes

Primary

MeasureTime frameDescription
VTE- and bleeding incidencefrom start of cancer diagnosis6- and 12-month VTE- and bleeding incidence

Secondary

MeasureTime frameDescription
Predictive performance of VTE risk factors and known prediction modelsfrom start cancer diagnosisTo 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 modelsfrom start cancer diagnosisPredictive performance of bleeding risk factors and known prediction models
Arterial thromboembolism (ATE) incidencefrom start of cancer diagnosis6- and 12-month ATE incidence

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026