NCT03646409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
542

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 11, 2018

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

August 23, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

August 24, 2018

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

January 13, 2020

Status Verified

January 1, 2020

Enrollment Period

4 months

First QC Date

August 23, 2018

Last Update Submit

January 8, 2020

Conditions

Venous ThromboembolismEsophagus CancerBleedingChemotherapy Effect

Outcome Measures

Primary Outcomes (1)

  • VTE- and bleeding incidence

    6- and 12-month VTE- and bleeding incidence

    from start of cancer diagnosis

Secondary Outcomes (3)

  • Predictive performance of VTE risk factors and known prediction models

    from start cancer diagnosis

  • Predictive performance of bleeding risk factors and known prediction models

    from start cancer diagnosis

  • Arterial thromboembolism (ATE) incidence

    from start of cancer diagnosis

Study Arms (1)

Patients with esophageal cancer receiving chemotherapy

Patients \> 18 years with esophageal cancer receiving neoadjuvant chemotherapy

Other: Venous thromboembolic event, arterial thromboembolic event, bleeding events

Interventions

Venous thromboembolic event, arterial thromboembolic event, bleeding eventsOTHER

Whether or not venous or arterial thromboembolic and bleeding events occur in patients with esophageal cancer receiving neoadjuvant chemotherapy

Patients with esophageal cancer receiving chemotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with esophageal cancer, receiving chemotherapy.

You may qualify if:

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

You may not qualify if:

  • \- Death \<3 months after cancer diagnosis (baseline)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Amsterdam UMC

Amsterdam, 1105 AZ, Netherlands

Location

Related Publications (6)

  • 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.

    PMID: 23908465BACKGROUND

  • 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. doi: 10.1002/cncr.23062.

    PMID: 17918266BACKGROUND

  • 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.

    PMID: 19398575BACKGROUND

  • 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.

    PMID: 18216292BACKGROUND

  • 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.

    PMID: 23908470BACKGROUND

  • 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. No abstract available.

    PMID: 22547369BACKGROUND

MeSH Terms

Conditions

Venous ThromboembolismEsophageal NeoplasmsHemorrhage

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsHead and Neck NeoplasmsDigestive System DiseasesEsophageal DiseasesGastrointestinal DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Harry R Büller, Prof. dr.

    Vascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. dr. H.R. Büller, principal investigator

Study Record Dates

First Submitted

August 23, 2018

First Posted

August 24, 2018

Study Start

June 11, 2018

Primary Completion

October 1, 2018

Study Completion

December 1, 2018

Last Updated

January 13, 2020

Record last verified: 2020-01

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)