Incidence of Blood Clots in Patients Undergoing Chemotherapy for Solid Tumors
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
|Breast Cancer Colorectal Cancer Gastric Cancer Lung Cancer Ovarian Cancer Pancreatic Cancer Prostate Cancer Thromboembolism||Other: clinical observation Procedure: management of therapy complications Procedure: ultrasound imaging|
|Official Title:||TEACH Survey (Thrombo-Embolism And Chemotherapy) A Prospective Survey on the Incidence of Venous Thromboembolic Events During Chemotherapy for Solid Tumors|
- Incidence of asymptomatic proximal deep vein thrombosis (DVT) of the lower limbs as assessed by bilateral compression ultrasound at baseline and at 3 months
- Incidence of symptomatic, proximal and/or distal DVT of the lower limbs as assessed by clinical diagnosis and compression ultrasound within 72 hours of detection of symptoms (during the 3-month observation period)
- Incidence of symptomatic pulmonary embolism as assessed by ventilation/perfusion lung scan, pulmonary angiogram, or CT lung scan within 72 hours of detection of symptoms or during autopsy (during the 3-month observation period)
|Study Start Date:||November 2006|
|Primary Completion Date:||March 2007 (Final data collection date for primary outcome measure)|
- Determine the incidence of venous thromboembolic events (i.e., deep vein thrombosis and/or pulmonary embolism) in patients undergoing chemotherapy for solid tumors.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00433602
|Amsterdam, Netherlands, 1066 EC|
|Study Chair:||Hans-Martin Otten, MD||Slotervaart Ziekenhuis|
|Study Chair:||Ullrich Bethe, MD||European Organisation for Research and Treatment of Cancer - EORTC|