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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2005

Longer than P75 for all trials

Geographic Reach
1 country

9 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

November 11, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 15, 2005

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

June 28, 2018

Status Verified

June 1, 2018

Enrollment Period

4.3 years

First QC Date

November 11, 2005

Last Update Submit

June 26, 2018

Conditions

Brain and Central Nervous System TumorsThromboembolism

Keywords

thromboembolismadult anaplastic astrocytomaadult anaplastic oligodendrogliomaadult glioblastomaadult giant cell glioblastomaadult gliosarcoma

Outcome Measures

Primary Outcomes (1)

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

    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

    on study

Interventions

laboratory biomarker analysisOTHER
physiologic testingOTHER
management of therapy complicationsPROCEDURE

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (9)

Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham

Birmingham, Alabama, 35294, United States

Location

H. Lee Moffitt Cancer Center and Research Institute at University of South Florida

Tampa, Florida, 33612-9497, United States

Location

Winship Cancer Institute of Emory University

Atlanta, Georgia, 30322, United States

Location

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

Baltimore, Maryland, 21231-2410, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Josephine Ford Cancer Center at Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Wake Forest University Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157-1096, United States

Location

Cleveland Clinic Taussig Cancer Center

Cleveland, Ohio, 44195, United States

Location

Abramson Cancer Center of the University of Pennsylvania

Philadelphia, Pennsylvania, 19104-4283, United States

Location

MeSH Terms

Conditions

Central Nervous System NeoplasmsThromboembolismAstrocytomaOligodendrogliomaGlioblastomaGliosarcoma

Condition Hierarchy (Ancestors)

Nervous System NeoplasmsNeoplasms by SiteNeoplasmsNervous System DiseasesEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Study Officials

  • Michael B. Streiff, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    STUDY CHAIR

  • Stuart A. Grossman, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

  • Larry Kleinberg, MD

    Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 11, 2005

First Posted

November 15, 2005

Study Start

April 1, 2005

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

June 28, 2018

Record last verified: 2018-06

Locations

US(9)