Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:14 PM
Ignite Modification Date:
2025-12-24 @ 11:14 PM
NCT ID:
NCT00253669
Brief 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.
Study:
NCT00253669
Study Brief:
Protocol Section:
NCT00253669