Study on Thrombosis Therapy in German Cancer Patients | NCT01559883

Studies
Study on Thrombosis Therapy in German Cancer Patients

NCT01559883

Sponsor

LEO Pharma

Status

Completed

Last Update Posted

Aug 15, 2014Estimated

Enrollment

76Actual

Phase

Not provided

Conditions

Cancer
Deep Vein Thrombosis
Pulmonary Embolism

Interventions

no intervention is being made

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Dec 2013Actual

Completion Date

Dec 2013Actual

First Submitted Date

Mar 1, 2012

First Submission Date that Met QC Criteria

Mar 19, 2012

First Posted Date

Mar 21, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 14, 2014

Last Update Posted Date

Aug 15, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

76Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
all eligible patients		there is only 1 Cohort in which all patients participating in this NIS are included	Other: no intervention is being made

Interventions

Name	Type	Description	Arm Group Labels	Other Names
no intervention is being made	Other	This is a Non-Interventional Study (NIS)	all eligible patients

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
treatment time on low molecular weight heparin		1 year

Secondary Outcomes

Measure	Description	Time Frame
patient pathways	data collection on patient pathway: who is the referring physician, physician who diagnoses deep vein thrombosis (DVT)	1 year
risk factors for DVT		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Axel Matzdorff, Prof.Dr.	Caritasklinikum Saarbrücken, St. Theresia	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Prof. Dr. Axel Matzdorff		Saarbrücken	Saarland	66111	Germany

Condition Browse Module

MeSH Terms

ID	Term
D009369	Neoplasms
D020246	Venous Thrombosis
D011655	Pulmonary Embolism
D013927	Thrombosis

Ancestor Terms

ID	Term
D016769	Embolism and Thrombosis
D014652	Vascular Diseases
D002318	Cardiovascular Diseases
D008171	Lung Diseases

Browse Leaves

Not provided

Browse Branches

Not provided