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The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01341171
Recruitment Status : Unknown
Verified April 2011 by University of Vermont.
Recruitment status was:  Active, not recruiting
First Posted : April 25, 2011
Last Update Posted : April 25, 2011
Sponsor:
Collaborator:
Information provided by:

Study Description
Brief Summary:
Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.

Condition or disease
Breast Cancer

Study Design

Study Type : Observational
Estimated Enrollment : 60 participants
Official Title: Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins
Study Start Date : August 2009
Primary Completion Date : October 2010
Estimated Study Completion Date : September 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
tamoxifen or aromatase inhibitors


Outcome Measures

Primary Outcome Measures :
  1. Angiogenic Protein levels [ Time Frame: following 6 months of therapy ]

Biospecimen Retention:   Samples Without DNA
serum, plasma, platelet activated samples

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women using tamoxifen or aromatase inhibitor therapy for greater than 6 months
Criteria

Inclusion Criteria:

  • women routinely taking tamoxifen or aromatase inhibitor therapy as prescribed by their oncologist

Exclusion Criteria:

  • Use of heparin, warfarin
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01341171


Locations
United States, Vermont
University of Vermont
Burlington, Vermont, United States, 05401
Sponsors and Collaborators
University of Vermont
American Cancer Society, Inc.
Investigators
Principal Investigator: Chris E Holmes, MD, PhD University of Vermont
More Information

Responsible Party: Chris E. Holmes, MD, PhD, University of Vermont
ClinicalTrials.gov Identifier: NCT01341171     History of Changes
Other Study ID Numbers: V0805
First Posted: April 25, 2011    Key Record Dates
Last Update Posted: April 25, 2011
Last Verified: April 2011

Keywords provided by University of Vermont:
tamoxifen
aromatase inhibitors
breast cancer
platelets

Additional relevant MeSH terms:
Tamoxifen
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action