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Completed

NCT Number: NCT00253669

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

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.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham, Birmingham, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

laboratory biomarker analysis

Other

Physiologic Testing

Other

management of therapy complications

Procedure

Primary outcomes

  1. Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism

    Time frame: until dvt or death

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Other

Collaborators

  • National Cancer Institute (NCI)
  • North American Brain Tumor Consortium

Registry information

Official study title

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

Important dates

Study start
2005
Primary completion
2009
Study completion
2009
First posted
Nov 15, 2005
Registry last updated
Jun 28, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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