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Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer (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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03646409
Recruitment Status : Completed
First Posted : August 24, 2018
Last Update Posted : January 13, 2020
Sponsor:
Information provided by (Responsible Party):
Harry R. Buller, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

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.

Condition or disease Intervention/treatment
Venous Thromboembolism Esophagus Cancer Bleeding Chemotherapy Effect Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events

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.

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Study Type : Observational
Actual Enrollment : 542 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Venous Thromboembolism and Bleeding Risk in Patients With Esophageal Cancer
Actual Study Start Date : June 11, 2018
Actual Primary Completion Date : October 1, 2018
Actual Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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




Primary Outcome Measures :
  1. VTE- and bleeding incidence [ Time Frame: from start of cancer diagnosis ]
    6- and 12-month VTE- and bleeding incidence


Secondary Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with esophageal cancer, receiving chemotherapy.
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

- Death <3 months after cancer diagnosis (baseline)


Information from the National Library of Medicine

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


Locations
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Netherlands
Amsterdam UMC
Amsterdam, Netherlands, 1105 AZ
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
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Principal Investigator: Harry R Büller, Prof. dr. Vascular Medicine
Publications:

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Responsible Party: Harry R. Buller, Prof. dr. H.R. Büller, principal investigator, Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
ClinicalTrials.gov Identifier: NCT03646409    
Other Study ID Numbers: thromboembolism and bleeding
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: January 13, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Esophageal Neoplasms
Thromboembolism
Venous Thromboembolism
Hemorrhage
Pathologic Processes
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Head and Neck Neoplasms
Digestive System Diseases
Esophageal Diseases
Gastrointestinal Diseases
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases