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TEACH survey, a prospective survey on the incidence of venous thromboembolic events during chemotherapy for solid tumors

Conditions
cancer
malign tumors
10027655
10014523
Registration Number
NL-OMON30286
Lead Sponsor
European Organisation for Research and Treatment of Cancer
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Pending
Sex
Not specified
Target Recruitment
30
Inclusion Criteria

- Age >= 18 years
- Patients who are scheduled to receive chemotherapy of >= 3 months
duration for cytologically or histologically proven:
o breast cancer (metastatic)
o colorectal cancer ((neo-) adjuvant or palliative chemotherapy)
o gastric cancer ((neo-) adjuvant or palliative chemotherapy)
o lung cancer ((neo-) adjuvant or palliative chemotherapy)
o ovarian cancer ((neo-) adjuvant or palliative chemotherapy)
o pancreatic cancer ((neo-) adjuvant or palliative chemotherapy)
o prostate cancer (hormone-refractory)
- Life expectancy of more than 3 months
- Informed consent given by patient for data collection and
ultrasonography

Exclusion Criteria

- No chemotherapy within 6 weeks before the start of the observation
period
- No major surgery including surgery for cancer within 4 weeks before the
start of the observation period
Note: minor surgery, e.g. implant of a port-a-cath, within these 4 weeks is
allowed.
- No major surgery including surgery for cancer planned during the
observation period
Note: Radiotherapy before or during the observation period is allowed.
- Patients with a history of DVT or PE can be included if treatment and
secondary prevention of the last episode was completed prior to survey
entry.
- No concurrent or scheduled use of thrombo-prophylaxis or any
anticoagulant therapy such as parenteral anticoagulants (heparin, low
molecular weight heparins or other agents such as fondaparinux,
bivalirudin), oral anticoagulants (vitamin K antagonists) or thrombolytic
agents

Study & Design

Study Type
Observational non invasive
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
<p>The primary endpoint is a composite of any of the following outcomes:<br /><br>* asymptomatic proximal deep vein thrombosis of the lower limbs<br /><br>* confirmed symptomatic deep vein thrombosis of the lower limbs<br /><br>* confirmed pulmonary embolism</p><br>
Secondary Outcome Measures
NameTimeMethod
<p>n.a.</p><br>
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