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The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Proteins

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2011 by University of Vermont.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
American Cancer Society, Inc.
Information provided by:
University of Vermont
ClinicalTrials.gov Identifier:
NCT01341171
First received: July 7, 2010
Last updated: April 21, 2011
Last verified: April 2011
History of Changes
  Purpose

Single phlebotomy study involving women receiving tamoxifen or aromatase inhibitor therapy.


Condition
Breast Cancer

Study Type: Observational
Official Title: Platelet Modulation in the Control of Angiogenesis: The Impact of Tamoxifen and Aromatase Inhibitors on Platelet Activation and Angiogenic Proteins

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Vermont:

Primary Outcome Measures:
  • Angiogenic Protein levels [ Time Frame: following 6 months of therapy ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

serum, plasma, platelet activated samples


Estimated Enrollment: 60
Study Start Date: August 2009
Estimated Study Completion Date: September 2012
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
tamoxifen or aromatase inhibitors

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders 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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Chris E. Holmes, MD, PhD, University of Vermont
ClinicalTrials.gov Identifier: NCT01341171     History of Changes
Other Study ID Numbers: V0805
Study First Received: July 7, 2010
Last Updated: April 21, 2011
Health Authority: United States: Institutional Review Board

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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Aromatase Inhibitors
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Therapeutic Uses
 Pharmacologic Actions
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Bone Density Conservation Agents
Estrogen Antagonists
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on June 18, 2013