Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
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 VTE - and bleeding incidence from the start of cancerdiagnosis in a retrospective cohort of patients with esophageal cancer from a database of Amsterdam UMC, and to determine the predicte value of the Khorana score and several other venous thromboembolic and bleeding prediction scores.

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.


Layout table for study information
Study Type : Observational
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Retrospective
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

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. 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

  2. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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


Contacts
Layout table for location contacts
Contact: Frits I Mulder, MD +31205661925 f.i.mulder@amc.uva.nl
Contact: Anne Hovenkamp a.hovenkamp@amc.uva.nl

Locations
Layout table for location information
Netherlands
Amsterdam UMC Recruiting
Amsterdam, Netherlands, 1105 AZ
Contact: Frits I Mulder, MD    +31205661925    f.i.mulder@amc.uva.nl   
Sub-Investigator: Anne Hovenkamp         
Sponsors and Collaborators
Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Investigators
Layout table for investigator information
Principal Investigator: Harry R Büller, Prof. dr. Vascular Medicine

Publications:

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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Hemorrhage
Esophageal Neoplasms
Thromboembolism
Venous Thromboembolism
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