Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Venous Thromboembolism Clinical Trial

— VENETIA  

Official title:

Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03646409
• Other study ID #: thromboembolism and bleeding
• Status: Completed
• Start date: June 11, 2018
• Est. completion date: December 1, 2018

Study information

• Verified date: January 2020
• Source: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 542
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Esophageal cancer patients

• Receiving chemotherapy

• Age at least 18 years old

Exclusion Criteria:

• Death <3 months after cancer diagnosis (baseline)

Related Conditions & MeSH terms

• Bleeding
• Chemotherapy Effect
• Esophageal Neoplasms
• Esophagus Cancer
• Hemorrhage
• Thromboembolism
• Venous Thromboembolism

Intervention

Other:
• Venous 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

Locations

Country	Name	City	State
Netherlands	Amsterdam UMC	Amsterdam

Sponsors (1)

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

Country where clinical trial is conducted

Netherlands, 

References & Publications (6)

Khorana 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. — View Citation

Khorana 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. — View Citation

Pabinger 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. Review. — View Citation

Starling 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. — View Citation

Timp 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. Review. — View Citation

Verso 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VTE- and bleeding incidence	6- and 12-month VTE- and bleeding incidence	from start of cancer diagnosis
Secondary	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
Secondary	Predictive performance of bleeding risk factors and known prediction models	Predictive performance of bleeding risk factors and known prediction models	from start cancer diagnosis
Secondary	Arterial thromboembolism (ATE) incidence	6- and 12-month ATE incidence	from start of cancer diagnosis