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


N/A
18 Years
N/A
Open (Enrolling)
Both
Advanced Cancer, Healthy

Thank you

Trial Information

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


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Lillian Siu, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Princess Margaret Hospital, Canada

Authority:

Canada: Ethics Review Committee

Study ID:

TEMs-DC-001

NCT ID:

NCT01543841

Start Date:

August 2012

Completion Date:

February 2014

Related Keywords:

  • Advanced Cancer
  • Healthy
  • advanced cancer
  • healthy
  • blood sample
  • TEM
  • TIE-2 expressing monocytes
  • ANG1
  • ANG2
  • Neoplasms

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