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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543841
• Other study ID #: TEMs-DC-001
• Status: Completed
• Start date: August 2012
• Est. completion date: January 2014

Study information

• Verified date: February 2019
• Source: University Health Network, Toronto
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Advanced Cancer
• Healthy
• Neoplasms

Locations

Country	Name	City	State
Canada	Princess Margaret Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
University Health Network, Toronto

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Develop and optimize flow cytometry analyses	This will comprise correlative studies in a separate upcoming Phase I clinical trial.	1 year