Clinical trial · Observational
Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer
NCT03646409CI-TRIAL-00042731VENETIAcompletedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bleeding | — | UNRESOLVED | — |
| Chemotherapy Effect | — | UNRESOLVED | — |
| Esophagus Cancer | — | UNRESOLVED | — |
| Venous Thromboembolism | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Venous thromboembolic event, arterial thromboembolic event, bleeding events | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Patients with esophageal cancer receiving chemotherapy
- description
- Patients \> 18 years with esophageal cancer receiving neoadjuvant chemotherapy
- interventionNames
- Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events
Primary outcomes (1)
- measure
- VTE- and bleeding incidence
- timeFrame
- from start of cancer diagnosis
- description
- 6- and 12-month VTE- and bleeding incidence
Secondary outcomes (3)
- measure
- Predictive performance of VTE risk factors and known prediction models
- timeFrame
- from start cancer diagnosis
- description
- To assess the predictive value of Khorana, modified Vienna-, and PROTECHT score in Predictive performance of VTE risk factors and known prediction models
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Esophageal cancer patients * Receiving chemotherapy * Age at least 18 years old Exclusion Criteria: \- Death \<3 months after cancer diagnosis (baseline)
References
Publications (6)
- BACKGROUNDTimp 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. PMID 23908465
- BACKGROUNDKhorana 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. PMID 17918266
- BACKGROUNDStarling 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. PMID 19398575
- BACKGROUNDKhorana 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. PMID 18216292
- BACKGROUNDPabinger 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. PMID 23908470
- BACKGROUNDVerso 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. PMID 22547369