Study on Thrombosis Therapy in German Cancer Patients

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

LEO Pharma

ClinicalTrials.gov Identifier:

NCT01559883

First received: March 1, 2012

Last updated: October 4, 2012

Last verified: October 2012

History of Changes

Tracking Information

First Received Date ^ICMJE

March 1, 2012

Last Updated Date

October 4, 2012

Start Date ^ICMJE

February 2012

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01559883 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Study on Thrombosis Therapy in German Cancer Patients

Official Title ^ICMJE

Study on Thrombosis Therapy in German Cancer Patients

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

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

Condition ^ICMJE

Cancer
Deep Vein Thrombosis
Pulmonary Embolism

Intervention ^ICMJE

Other: no intervention is being made

This is a Non-Interventional Study (NIS)

Study Group/Cohort (s)

all eligible patients

there is only 1 Cohort in which all patients participating in this NIS are included

Intervention: Other: no intervention is being made

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

July 2013

Estimated Primary Completion Date

July 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01559883

Other Study ID Numbers ^ICMJE

DE-Thrombose-NIS-2012

Has Data Monitoring Committee

Responsible Party

LEO Pharma

Study Sponsor ^ICMJE

LEO Pharma

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Axel Matzdorff, Prof.Dr.

Caritasklinikum Saarbrücken, St. Theresia

Information Provided By

LEO Pharma

Verification Date

October 2012

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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