Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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 | Intervention |
|---|---|
|
Brain and Central Nervous System Tumors Thromboembolism |
Other: laboratory biomarker analysis Other: physiologic testing Procedure: management of therapy complications |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Prospective |
| Official Title: | Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas |
- Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism [ Time Frame: until dvt or death ] [ Designated as safety issue: Yes ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 110 |
| Study Start Date: | April 2005 |
| Study Completion Date: | August 2009 |
| Primary Completion Date: | August 2009 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
outpatient clinic
DISEASE CHARACTERISTICS:
Histologically confirmed newly diagnosed malignant brain tumor
Supratentorial grade III or IV astrocytoma of 1 of the following types:
- Anaplastic astrocytoma
- Anaplastic oligodendroglioma
- Glioblastoma multiforme
- No prior thrombotic event
PATIENT CHARACTERISTICS:
Performance status
- Karnofsky 60-100%
Life expectancy
- Not specified
Hematopoietic
- Not specified
Hepatic
- Not specified
Renal
- Not specified
PRIOR CONCURRENT THERAPY:
Biologic therapy
- No prior immunotherapy or biologic agents, including immunotoxins, immunoconjugates, antisense therapy, peptide-receptor antagonists, interferons, interleukins, tumor-infiltrating lymphocytes, lymphocyte-activated killer cells, or gene therapy, for the brain tumor
Chemotherapy
- No prior chemotherapy for the brain tumor except polifeprosan 20 with carmustine implant (Gliadel wafer)
Endocrine therapy
- No prior hormonal therapy for the brain tumor except glucocorticoids
Radiotherapy
- No prior radiotherapy for the brain tumor
- No prior cranial irradiation
Other
- No concurrent chronic anticoagulation therapy
Contacts and Locations| 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 |
More Information
Additional Information:
No publications provided
| Responsible Party: | Sidney Kimmel Comprehensive Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00253669 History of Changes |
| Other Study ID Numbers: | NABTT-0307 CDR0000441111, U01CA062475, NABTT-0307, JHOC-NABTT-0307 |
| Study First Received: | November 11, 2005 |
| Last Updated: | May 24, 2012 |
| Health Authority: | United States: Federal Government |
Keywords provided by Sidney Kimmel Comprehensive Cancer Center:
|
thromboembolism adult anaplastic astrocytoma adult anaplastic oligodendroglioma |
adult glioblastoma adult giant cell glioblastoma adult gliosarcoma |
Additional relevant MeSH terms:
|
Nervous System Neoplasms Thromboembolism Central Nervous System Neoplasms Neoplasms by Site Neoplasms |
Nervous System Diseases Embolism and Thrombosis Vascular Diseases Cardiovascular Diseases Thrombosis |
ClinicalTrials.gov processed this record on May 21, 2013