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

Study Overview
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Brief Summary
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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.

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

Conditions
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Advanced Cancer, Healthy

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Advanced Cancer<br>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<br>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?
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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 | 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 | This will comprise correlative studies in a separate upcoming Phase I clinical trial. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced cancer, healthy, blood sample, TEM, TIE-2 expressing monocytes, ANG1, ANG2