Laboratory Testing for Tie-2 Expressing Monocytes (TEMs) in Blood

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01543841
Recruitment Status : Completed
First Posted : March 5, 2012
Last Update Posted : April 17, 2015
Information provided by (Responsible Party):
University Health Network, Toronto

Brief Summary:

Tie-2 expressing monocytes (TEMs) are a specific type of blood cell that are present in healthy individuals and in people with cancer. These cells may play a role in the growth of blood vessels (veins/arteries), and may be particularly important in the growth of blood vessels that supply tumours. Understanding how these cells work may therefore help researchers to develop cancer treatments that starve tumors of their blood supply.

This research study involves an analysis of the behaviour of blood cells in response to different drugs in a test tube. The goal is to develop tests that can then be used to monitor patients treated with drugs that target blood vessel growth.

Condition or disease
Advanced Cancer Healthy

Study Type : Observational
Actual Enrollment : 20 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: A Laboratory Evaluation of Tie-2 Expressing Monocytes (TEMs) in Healthy Volunteers and Patients With Advanced Cancer
Study Start Date : August 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : January 2014

Advanced Cancer
Healthy Volunteers

Primary Outcome Measures :
  1. Characterize the in vitro response of circulating myeloid cells to angiopoeitins-1 and 2 (ANG1 and 2) in the presence or absence of pharmacologic inhibitors [ Time Frame: 1 year ]
    This is an observational correlative laboratory protocol in which one tube of blood from healthy volunteers and cancer patients will be collected to perform in vitro stimulation of TEMs with ANG1 and 2 and flow cytometry analysis, which could serve as a biomarker for future ANG directed therapies. The results of this study will contribute to an improved understanding of ANG-TIE2 signaling in TEMs. Furthermore, this study will contribute directly to the development and optimization of protocols that will be applied a separate Phase I NCI trial of AMG 386 and temsirolimus.

Secondary Outcome Measures :
  1. Develop and optimize flow cytometry analyses [ Time Frame: 1 year ]
    This will comprise correlative studies in a separate upcoming Phase I clinical trial.

Biospecimen Retention:   None Retained
One tube of whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with advanced cancer attending the Phase I clinic and healthy staff at the Princess Margaret Hospital

Inclusion Criteria:

  • Healthy volunteers

    • Ability to understand and the willingness to sign a written informed consent document.
  • Patients with advancer cancer

    • Participants must have histologically confirmed metastatic or unresectable solid tumors.
    • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Healthy volunteers

    • History of cancer within the past 5 years
    • Major medical condition undergoing active therapy
  • Patients with advancer cancer

    • Active hematologic malignancy (leukemia, lymphoma, myeloproliferative disorder).
    • Active treatment on a Phase I clinical trial

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01543841

Canada, Ontario
Princess Margaret Hospital
Toronto, Ontario, Canada, M5G 2M9
Sponsors and Collaborators
University Health Network, Toronto
Principal Investigator: Lillian Siu, MD Princess Margaret Hospital, Canada

Responsible Party: University Health Network, Toronto Identifier: NCT01543841     History of Changes
Other Study ID Numbers: TEMs-DC-001
First Posted: March 5, 2012    Key Record Dates
Last Update Posted: April 17, 2015
Last Verified: April 2015

Keywords provided by University Health Network, Toronto:
advanced cancer
blood sample
TIE-2 expressing monocytes

Additional relevant MeSH terms: