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

NCT ID: NCT01543841

Last Updated: 2019-02-15

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 20 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2012-08-31
• Study Completion Date: 2014-01-31

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.

Conditions

Advanced Cancer; Healthy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University Health Network, Toronto

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lillian Siu, MD

Role: PRINCIPAL_INVESTIGATOR

Princess Margaret Hospital, Canada

Locations

Princess Margaret Hospital

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

TEMs-DC-001

Identifier Type: -

Identifier Source: org_study_id