Study on Thrombosis Therapy in German Cancer Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
LEO Pharma
ClinicalTrials.gov Identifier:
NCT01559883
First received: March 1, 2012
Last updated: August 14, 2014
Last verified: November 2013
  Purpose

The study aims to document the flow of German patients with cancer and acute deep vein thrombosis from first visit to diagnosis and treatment, the applied diagnostic procedures, and therapy modalities.


Condition Intervention
Cancer
Deep Vein Thrombosis
Pulmonary Embolism
Other: no intervention is being made

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Study on Thrombosis Therapy in German Cancer Patients

Resource links provided by NLM:


Further study details as provided by LEO Pharma:

Primary Outcome Measures:
  • treatment time on low molecular weight heparin [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • patient pathways [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    data collection on patient pathway: who is the referring physician, physician who diagnoses deep vein thrombosis (DVT)

  • risk factors for DVT [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Enrollment: 76
Study Start Date: February 2012
Study Completion Date: December 2013
Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
all eligible patients
there is only 1 Cohort in which all patients participating in this NIS are included
Other: no intervention is being made
This is a Non-Interventional Study (NIS)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Cancer patient with acute deep vein throbosis/ pulmonary embolism in ambulatory oncology care/practice

Criteria

Inclusion Criteria:

  • patient with cancer and acute deep vein thrombosis and/or pulmonary embolism

Exclusion Criteria:

  • life expectancy less that 6 months
  • age less that 18 years
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559883

Locations
Germany
Prof. Dr. Axel Matzdorff
Saarbrücken, Saarland, Germany, 66111
Sponsors and Collaborators
LEO Pharma
Investigators
Principal Investigator: Axel Matzdorff, Prof.Dr. Caritasklinikum Saarbrücken, St. Theresia
  More Information

No publications provided

Responsible Party: LEO Pharma
ClinicalTrials.gov Identifier: NCT01559883     History of Changes
Other Study ID Numbers: DE-Thrombose-NIS-2012
Study First Received: March 1, 2012
Last Updated: August 14, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by LEO Pharma:
cancer
thrombosis
pulmonary embolism
anticoagulation
low molecular weight heparin

Additional relevant MeSH terms:
Thrombosis
Embolism
Pulmonary Embolism
Venous Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 29, 2014