NCT00253669

Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas

Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 110 (actual)
• Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins · Academic / Other
• Sex: All
• Age: 18 Years – 120 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

OBJECTIVES: Primary * 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. Secondary * 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.

Conditions

• Brain and Central Nervous System Tumors
• Thromboembolism

Interventions

Type	Name	Description
OTHER	laboratory biomarker analysis
OTHER	physiologic testing
PROCEDURE	management of therapy complications

Timeline

• Start date: 2005-04-01
• Primary completion: 2009-08-01
• Completion: 2009-08-01
• First posted: 2005-11-15
• Last updated: 2018-06-28

Locations

9 sites across 1 country: United States