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Tracking Information | |||||||||
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First Received Date † | February 8, 2007 | ||||||||
Last Updated Date | February 6, 2009 | ||||||||
Start Date † | November 2006 | ||||||||
Current Primary Outcome Measures † |
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Original Primary Outcome Measures † | Same as current | ||||||||
Change History | Complete list of historical versions of study NCT00433602 on ClinicalTrials.gov Archive Site | ||||||||
Current Secondary Outcome Measures † | |||||||||
Original Secondary Outcome Measures † | |||||||||
Descriptive Information | |||||||||
Brief Title † | Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors | ||||||||
Official Title † | TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors | ||||||||
Brief Summary | RATIONALE: Chemotherapy may cause blood clots to form in the thigh, leg, and lung. This study may help doctors understand how often blood clots occur in patients undergoing chemotherapy. PURPOSE: This clinical trial is studying how often blood clots occur in patients undergoing chemotherapy for solid tumors, including colorectal cancer, stomach cancer, lung cancer, ovarian cancer, pancreatic cancer, prostate cancer, or metastatic breast cancer |
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Detailed Description | OBJECTIVES:
OUTLINE: This is a prospective, multicenter survey. Patients undergo observation beginning on day 1 of chemotherapy and continuing for up to 3 months in the absence of symptomatic, confirmed deep vein thrombosis or pulmonary embolism; use of anticoagulant therapy for more than 5 days as curative treatment; or initiation of thromboprophylaxis for any reason. Patients undergo bilateral compression ultrasound of the lower limbs at baseline and at 3 months (or at an earlier timepoint, if indicated). PROJECTED ACCRUAL: A total of 2,000 patients will be accrued for this study. |
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Study Phase | |||||||||
Study Type † | Observational | ||||||||
Study Design † | |||||||||
Condition † |
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Intervention † |
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Study Arms / Comparison Groups | |||||||||
Publications * | |||||||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status † | Active, not recruiting | ||||||||
Enrollment † | 2000 | ||||||||
Completion Date | |||||||||
Primary Completion Date | |||||||||
Eligibility Criteria † | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Gender | Both | ||||||||
Ages | 18 Years and older | ||||||||
Accepts Healthy Volunteers | No | ||||||||
Contacts †† | |||||||||
Location Countries † | Netherlands | ||||||||
Expanded Access Status | |||||||||
Administrative Information | |||||||||
NCT ID † | NCT00433602 | ||||||||
Responsible Party | |||||||||
Secondary IDs †† | EORTC-90051, SANOFI-AVENTIS-EORTC-90051 | ||||||||
Study Sponsor † | European Organization for Research and Treatment of Cancer | ||||||||
Collaborators †† | |||||||||
Investigators † |
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Information Provided By | National Cancer Institute (NCI) | ||||||||
Verification Date | April 2007 | ||||||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |