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

February 13, 2019 updated by: University Health Network, Toronto

A Laboratory Evaluation of Tie-2 Expressing Monocytes (TEMs) in Healthy Volunteers and Patients With Advanced Cancer

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

20

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • Princess Margaret Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients with advanced cancer attending the Phase I clinic and healthy staff at the Princess Margaret Hospital

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Advanced Cancer
Patients with histologically confirmed metastatic or unresectable solid tumors will have one tube of whole blood (~6mL) collected at the time of venipuncture for routine sample collection. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis.
Healthy Volunteers
Eligible volunteers will have one tube of whole blood (~6mL) collected. The sample will undergo in vitro stimulation of TEMs with ANG 1 and 3 in the presence or absence of pharmalogic inhibitors, and flow cytometry analysis.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

January 1, 2014

Study Registration Dates

First Submitted

January 19, 2012

First Submitted That Met QC Criteria

February 27, 2012

First Posted (ESTIMATE)

March 5, 2012

Study Record Updates

Last Update Posted (ACTUAL)

February 15, 2019

Last Update Submitted That Met QC Criteria

February 13, 2019

Last Verified

February 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TEMs-DC-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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