CancerNCT01559883
Study on Thrombosis Therapy in German Cancer Patients
An observational study of Cancer and Deep Vein Thrombosis, run by LEO Pharma at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer, Deep Vein Thrombosis, Pulmonary Embolism
- How many people
- 76 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Cancer patient with acute deep vein throbosis/ pulmonary embolism in ambulatory oncology care/practice
Who may be able to join
- patient with cancer and acute deep vein thrombosis and/or pulmonary embolism
Who cannot join
- life expectancy less that 6 months
- age less that 18 years
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer, Deep Vein Thrombosis, Pulmonary Embolism
- Being tested
- no intervention is being made
- Keywords
- cancer, thrombosis, pulmonary embolism, anticoagulation, low molecular weight heparin
- Medical subject headings
- Neoplasms, Venous Thrombosis, Pulmonary Embolism, Thrombosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no intervention is being madeOther
This is a Non-Interventional Study (NIS)
| Study group | Role | What they receive |
|---|---|---|
| all eligible patients | there is only 1 Cohort in which all patients participating in this NIS are included Receives: Other: no intervention is being made |
What is being measured
The primary outcome is the main question the study is designed to answer.
treatment time on low molecular weight heparin
Measured: 1 year
Secondary outcomes (2)
patient pathways
data collection on patient pathway: who is the referring physician, physician who diagnoses deep vein thrombosis (DVT)
Measured: 1 year
risk factors for DVT
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- LEO Pharma
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Axel Matzdorff, Prof.Dr., Principal investigator, Caritasklinikum Saarbrücken, St. Theresia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01559883
- Sponsor's protocol ID
- DE-Thrombose-NIS-2012
- Status last verified
- Nov 2013
- First submitted
- 1 Mar 2012
- Last updated
- 15 Aug 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Thrombosis Therapy in German Cancer Patients
- ClinicalTrials.gov ID
- NCT01559883
- Acronym / sponsor ID
- DE-Thrombose-NIS-2012
- Conditions
- Cancer, Deep Vein Thrombosis, Pulmonary Embolism
- Keywords
- cancer, thrombosis, pulmonary embolism, anticoagulation, low molecular weight heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- LEO PharmaIndustry (pharma, biotech, devices)
- Study start
- Feb 2012
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 21 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| all eligible patients | – | Other: no intervention is being madethere is only 1 Cohort in which all patients participating in this NIS are included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Cancer patient with acute deep vein throbosis/ pulmonary embolism in ambulatory oncology care/practice
Key inclusion criteria (1 listed)
- patient with cancer and acute deep vein thrombosis and/or pulmonary embolism
Key exclusion criteria (2 listed)
- life expectancy less that 6 months
- age less that 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| no intervention is being madeThis is a Non-Interventional Study (NIS) | Other | all eligible patients |
Primary outcome
treatment time on low molecular weight heparin
Time frame: 1 year
2 secondary outcomes
patient pathways
Time frame: 1 year
risk factors for DVT
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Aug 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Axel Matzdorff, Prof.Dr. principal investigator
Caritasklinikum Saarbrücken, St. Theresia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer and Deep Vein Thrombosis, run by LEO Pharma at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
treatment time on low molecular weight heparin (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Aug 2014.