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

This study is currently recruiting participants.
Verified August 2012 by University Health Network, Toronto
Sponsor:
Information provided by (Responsible Party):
University Health Network, Toronto
ClinicalTrials.gov Identifier:
NCT01543841
First received: January 19, 2012
Last updated: August 20, 2012
Last verified: August 2012
History of Changes
  Purpose

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
Advanced Cancer
Healthy

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

MedlinePlus related topics: Cancer
U.S. FDA Resources

Further study details as provided by University Health Network, Toronto:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    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:
  • Develop and optimize flow cytometry analyses [ Time Frame: 1 year ] [ Designated as safety issue: No ]
    This will comprise correlative studies in a separate upcoming Phase I clinical trial.


Biospecimen Retention:   None Retained

One tube of whole blood


Estimated Enrollment: 20
Study Start Date: August 2012
Estimated Study Completion Date: February 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Advanced Cancer
Healthy Volunteers

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01543841

Contacts
Contact: David Cescon, MD dave.cescon@uhn.ca

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

No publications provided

Responsible Party: University Health Network, Toronto
ClinicalTrials.gov Identifier: NCT01543841     History of Changes
Other Study ID Numbers: TEMs-DC-001
Study First Received: January 19, 2012
Last Updated: August 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by University Health Network, Toronto:
advanced cancer
healthy
blood sample
TEM
 TIE-2 expressing monocytes
ANG1
ANG2

Additional relevant MeSH terms:
Neoplasms

ClinicalTrials.gov processed this record on June 17, 2013