Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer: a Retrospective Study (VENETIA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03646409|
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 24, 2018
|Condition or disease||Intervention/treatment|
|Venous Thromboembolism Esophagus Cancer Bleeding Chemotherapy Effect||Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events|
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.
|Study Type :||Observational|
|Estimated Enrollment :||500 participants|
|Official Title:||Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer: a Retrospective Study|
|Actual Study Start Date :||June 11, 2018|
|Estimated Primary Completion Date :||October 1, 2018|
|Estimated Study Completion Date :||December 1, 2018|
Patients with esophageal cancer receiving chemotherapy
Patients > 18 years with esophageal cancer receiving neoadjuvant chemotherapy
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
- VTE- and bleeding incidence [ Time Frame: from start of cancer diagnosis ]6- and 12-month VTE- and bleeding incidence
- to assess value of VTE predictive models [ Time Frame: from start cancer diagnosis ]To assess the predictive value of Khorana, modified Vienna-, and PROTECHT score in predicting VTE
- to assess value of bleeding predictive models [ Time Frame: from start cancer diagnosis ]To assess the predictive value of the VTE-BLEED, Kuijer, RIETE, EINSTEIN, and Hokusai score in predicting bleeding events
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646409
|Contact: Frits I Mulder, MDfirstname.lastname@example.org|
|Contact: Anne Hovenkampemail@example.com|
|Amsterdam, Netherlands, 1105 AZ|
|Contact: Frits I Mulder, MD +31205661925 firstname.lastname@example.org|
|Sub-Investigator: Anne Hovenkamp|
|Principal Investigator:||Harry R Büller, Prof. dr.||Vascular Medicine|