Brain and Central Nervous System TumorsNCT00253669
Risk Factors for Developing a Blood Clot in Patients Who Are Undergoing Cancer Treatment for Newly Diagnosed Gliomas
An observational study of Brain and Central Nervous System Tumors and Thromboembolism, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Brain and Central Nervous System Tumors, Thromboembolism
- What is being tested?
- laboratory biomarker analysis, physiologic testing and management of therapy complications
- Type of treatment
- Surgery or procedure
- How many people
- 110 participants
- Where
- 9 sitesUnited States
- Study dates
- Apr 2005to Aug 2009
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
United States9 sites
Winship Cancer Institute of Emory University
Atlanta, Georgia, 30322
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21231-2410
Lurleen Wallace Comprehensive Cancer at University of Alabama - Birmingham
Birmingham, Alabama, 35294
Massachusetts General Hospital
Boston, Massachusetts, 02114
Cleveland Clinic Taussig Cancer Center
Cleveland, Ohio, 44195
Josephine Ford Cancer Center at Henry Ford Hospital
Detroit, Michigan, 48202
Abramson Cancer Center of the University of Pennsylvania
Philadelphia, Pennsylvania, 19104-4283
H. Lee Moffitt Cancer Center and Research Institute at University of South Florida
Tampa, Florida, 33612-9497
Wake Forest University Comprehensive Cancer Center
Winston-Salem, North Carolina, 27157-1096
About this study
Official title: Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade 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.
Read the 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.
- Being tested
- laboratory biomarker analysis, physiologic testing, management of therapy complications
- Keywords
- thromboembolism, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Medical subject headings
- Central Nervous System Neoplasms, Thromboembolism, Astrocytoma, Oligodendroglioma, Glioblastoma, Gliosarcoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laboratory biomarker analysisOther
physiologic testingOther
management of therapy complicationsProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism
Measured: 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
Measured: on study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Nov 2005 (estimated)
- Study startApr 2005
- Primary completionAug 2009
- Study completionAug 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain and Central Nervous System TumorsStudies of the same condition, open and under way.
- More trials run by Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), North American Brain Tumor Consortium
- Responsible party
- Sponsor
- Investigators
- Michael B. Streiff, MD, Study chair, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsStuart A. Grossman, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsLarry Kleinberg, MD, Principal investigator, Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00253669
- Sponsor's protocol ID
- NABTT-0307
- Other IDs
- U01CA062475, CDR0000441111, JHOC-NABTT-0307
- Status last verified
- Jun 2018
- First submitted
- 11 Nov 2005
- Last updated
- 28 Jun 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Thrombophilic States in Newly Diagnosed Patients With High-Grade Gliomas
- ClinicalTrials.gov ID
- NCT00253669
- Acronym / sponsor ID
- NABTT-0307
- Keywords
- thromboembolism, adult anaplastic astrocytoma, adult anaplastic oligodendroglioma, adult glioblastoma, adult giant cell glioblastoma, adult gliosarcoma
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Sidney Kimmel Comprehensive Cancer Center at Johns HopkinsUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), North American Brain Tumor Consortium
- Study start
- Apr 2005
- Primary completion
- Aug 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 15 Nov 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- outpatient clinic
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| laboratory biomarker analysis | Other | – |
| physiologic testing | Other | – |
| management of therapy complications | Procedure or surgery | – |
Primary outcome
Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism
Time frame: until dvt or death
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael B. Streiff, MD study chair
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Stuart A. Grossman, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Larry Kleinberg, MD principal investigator
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Brain and Central Nervous System Tumors and Thromboembolism, run by Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins at 9 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thrombosis-free survival as assessed by objectively documented deep vein thrombosis or pulmonary embolism (time frame: until dvt or death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2018.