Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00253669|
Recruitment Status : Completed
First Posted : November 15, 2005
Last Update Posted : May 28, 2012
RATIONALE: Patients with gliomas may be at risk for developing blood clots. Learning about the risk factors for developing blood clots may help doctors plan better treatment for gliomas.
PURPOSE: This clinical trial is studying risk factors for developing blood clots in patients who are undergoing cancer treatment for newly diagnosed gliomas.
|Condition or disease||Intervention/treatment|
|Brain and Central Nervous System Tumors Thromboembolism||Other: laboratory biomarker analysis Other: physiologic testing Procedure: management of therapy complications|
- Determine the overall hazard rate of first venous thromboembolism per person-year of follow-up in patients undergoing antineoplastic therapy for newly diagnosed high-grade gliomas.
- Correlate ABO blood type with incidence of venous thromboembolism in these patients.
- Correlate factor VIII level with incidence of venous thromboembolism in these patients.
- Determine the overall and individual incidence rate of thromboembolism in these patients.
- Correlate clinical variables, such as type of antineoplastic treatments, Karnofsky performance status, and type of tumor, with incidence of venous thromboembolism in these patients.
- Correlate demographic factors, such as age, with incidence of venous thromboembolism in these patients.
OUTLINE: This is a pilot, multicenter study.
Patients undergo blood collection for blood typing (if not already obtained) and factor VIII and C-reactive protein levels at baseline. Patients are followed to obtain information on their Karnofsky performance status, treatment they receive for their brain tumor, and occurrence of any thrombotic events (e.g., pulmonary embolism or deep-vein thrombosis). Patients are followed every 28 days until the development of thrombotic events, after which they are followed every 2 months for survival.
PROJECTED ACCRUAL: A total of 107 patients will be accrued for this study.
|Study Type :||Observational|
|Actual Enrollment :||110 participants|
|Observational Model:||Case Control|
|Official Title:||Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas|
|Study Start Date :||April 2005|
|Actual Primary Completion Date :||August 2009|
|Actual Study Completion Date :||August 2009|
- Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism [ Time Frame: until dvt or death ]
- ABO blood group association with venous thromboembolism (VTE) factor VIII activity and VTE as assessed by laboratory test result at study entry [ Time Frame: on study ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00253669
|United States, Alabama|
|Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham|
|Birmingham, Alabama, United States, 35294|
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute at University of South Florida|
|Tampa, Florida, United States, 33612-9497|
|United States, Georgia|
|Winship Cancer Institute of Emory University|
|Atlanta, Georgia, United States, 30322|
|United States, Maryland|
|Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins|
|Baltimore, Maryland, United States, 21231-2410|
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|United States, Michigan|
|Josephine Ford Cancer Center at Henry Ford Hospital|
|Detroit, Michigan, United States, 48202|
|United States, North Carolina|
|Wake Forest University Comprehensive Cancer Center|
|Winston-Salem, North Carolina, United States, 27157-1096|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Center|
|Cleveland, Ohio, United States, 44195|
|United States, Pennsylvania|
|Abramson Cancer Center of the University of Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19104-4283|
|Study Chair:||Michael B. Streiff, MD||Sidney Kimmel Comprehensive Cancer Center|
|Principal Investigator:||Stuart A. Grossman, MD||Sidney Kimmel Comprehensive Cancer Center|
|Principal Investigator:||Larry Kleinberg, MD||Sidney Kimmel Comprehensive Cancer Center|