Venous ThromboembolismNCT00201903
The Roles of Tissue Factor in Malignant Gliomas
An observational study of Venous Thromboembolism and Brain Tumors, run by Ontario Clinical Oncology Group (OCOG) at 6 sites in 2 countries.
Trial summary
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Venous Thromboembolism, Brain Tumors
- How many people
- 30 participants
- Where
- 6 sitesin 2 countries
- Study dates
- Jan 2004to Oct 2006
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- participation in PRODIGE
- adult patients
- newly diagnosed, biopsy-confirmed grade III/IV malignant gliomas
- undergone craniotomy or stereotactic biopsy > 2 days and < 4 weeks before
Who cannot join
- have known hereditary thrombophilia
- are receiving experimental antiangiogenic therapy
Trial locations and contacts
6 sites in 2 countries.
6 sites in 2 countries
Canada4 sites
Cross Cancer Institute
Edmonton, Alberta, T6G 1Z2
Toronto-Sunnybrook Regional Cancer Centre
Toronto, Ontario, M4N 3M5
Princess Margaret Hospital
Toronto, Ontario, M5G 2M9
CancerCare Manitoba
Winnipeg, Manitoba, R3E 0V9
United States2 sites
Henry Ford Hospital
Detroit, Michigan, 48202
Huntsman Cancer Institute
Salt Lake City, Utah, 84112-5550
About this study
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma
Read the detailed description
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma
- Conditions
- Venous Thromboembolism, Brain Tumors
- Keywords
- venous thromboembolism, brain tumours, glioma, tissue factor, blood coagulation, tumour progression, low molecular weight heparin
- Medical subject headings
- Venous Thromboembolism, Brain Neoplasms, Glioma, Thrombosis, Disease Progression
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startJan 2004
- Study completionOct 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Venous ThromboembolismStudies of the same condition, open and under way.
- 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
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Cancer Research Network
- Investigators
- Agnes Lee, MD, Study chair, Hamilton Health Sciences and McMaster UniversityWilliam Geerts, MD, Principal investigator, Sunnybrook Health Sciences CentreMark Levine, MD, Principal investigator, Ontario Clinical Oncology Group (OCOG)James Perry, MD, Principal investigator, Toronto Sunnybrook Regional Cancer CentreJanusz Rak, Principal investigator, Hamilton Health Sciences and McMaster UniversityJeffrey Weitz, MD, Principal investigator, Hamilton Health Sciences and McMaster University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00201903
- Sponsor's protocol ID
- OCOG-2003-TFsubstudy
- Status last verified
- May 2007
- First submitted
- 13 Sep 2005
- Last updated
- 6 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Roles of Tissue Factor in Malignant Gliomas
- ClinicalTrials.gov ID
- NCT00201903
- Acronym / sponsor ID
- OCOG-2003-TFsubstudy
- Conditions
- Venous Thromboembolism, Brain Tumors
- Keywords
- venous thromboembolism, brain tumours, glioma, tissue factor, blood coagulation, tumour progression, low molecular weight heparin
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Ontario Clinical Oncology Group (OCOG)University, hospital or other
- Collaborators
- Ontario Cancer Research Network
- Study start
- Jan 2004
- Study completion
- Oct 2006 (actual)
- First posted
- 20 Sep 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.
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma
Detailed description
To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma
Study design
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- participation in PRODIGE
- adult patients
- newly diagnosed, biopsy-confirmed grade III/IV malignant gliomas
- undergone craniotomy or stereotactic biopsy > 2 days and < 4 weeks before
Key exclusion criteria (2 listed)
- have known hereditary thrombophilia
- are receiving experimental antiangiogenic therapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
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 6 Apr 2017.
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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.
Agnes Lee, MD study chair
Hamilton Health Sciences and McMaster University
William Geerts, MD principal investigator
Sunnybrook Health Sciences Centre
Mark Levine, MD principal investigator
Ontario Clinical Oncology Group (OCOG)
6 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Venous Thromboembolism and Brain Tumors, run by Ontario Clinical Oncology Group (OCOG) at 6 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. 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 6 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Canada, 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.
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 6 Apr 2017.