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

Completed

• Conditions: Advanced Cancer; Healthy

• Registration Number: NCT01543841
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-19
• Study First Submitted QC: 2012-02-27
• Study First Posted: 2012-03-05
• Study Start: 2012-08
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2019-02
• Last Update Submitted: 2019-02-13
• Last Update Posted: 2019-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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.

Read More

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

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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	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

Name	Time	Method
Develop and optimize flow cytometry analyses	1 year	This will comprise correlative studies in a separate upcoming Phase I clinical trial.

Trial Locations

Locations (1)

Princess Margaret Hospital; 🇨🇦 Toronto, Ontario, Canada