NCT00201903

Brief Summary

To explore the relationship between tissue factor levels, tumour progression, activation of blood coagulation and venous thromboembolism with malignant glioma

Trial Health

90
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2004

Typical duration for all trials

Geographic Reach
2 countries

6 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

January 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2006

Completed
Last Updated

April 6, 2017

Status Verified

May 1, 2007

First QC Date

September 13, 2005

Last Update Submit

April 5, 2017

Conditions

Venous ThromboembolismBrain Tumors

Keywords

venous thromboembolismbrain tumoursgliomatissue factorblood coagulationtumour progressionlow molecular weight heparin

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • have known hereditary thrombophilia
  • are receiving experimental antiangiogenic therapy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Huntsman Cancer Institute

Salt Lake City, Utah, 84112-5550, United States

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Toronto-Sunnybrook Regional Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Location

MeSH Terms

Conditions

Venous ThromboembolismBrain NeoplasmsGliomaThrombosisDisease Progression

Condition Hierarchy (Ancestors)

ThromboembolismEmbolism and ThrombosisVascular DiseasesCardiovascular DiseasesCentral Nervous System NeoplasmsNervous System NeoplasmsNeoplasms by SiteNeoplasmsBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasms, Glandular and EpithelialNeoplasms, Nerve TissueDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Agnes Lee, MD

    Hamilton Health Sciences and McMaster University

    STUDY CHAIR

  • William Geerts, MD

    Sunnybrook Health Sciences Centre

    PRINCIPAL INVESTIGATOR

  • Mark Levine, MD

    Ontario Clinical Oncology Group (OCOG)

    PRINCIPAL INVESTIGATOR

  • James Perry, MD

    Toronto Sunnybrook Regional Cancer Centre

    PRINCIPAL INVESTIGATOR

  • Janusz Rak

    Hamilton Health Sciences and McMaster University

    PRINCIPAL INVESTIGATOR

  • Jeffrey Weitz, MD

    Hamilton Health Sciences and McMaster University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 20, 2005

Study Start

January 1, 2004

Study Completion

October 1, 2006

Last Updated

April 6, 2017

Record last verified: 2007-05

Locations

CA(4)US(2)