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Completed

NCT Number: NCT01543841

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

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.

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Key information

Conditions

Advanced Cancer Healthy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Princess Margaret Hospital

Toronto, Ontario, M5G 2M9, Canada

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Develop and optimize flow cytometry analyses

    Time frame: 1 year

    This will comprise correlative studies in a separate upcoming Phase I clinical trial.

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Mar 5, 2012
Registry last updated
Feb 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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