Total Xenoestrogen Body Burden in Relation to Mammographic Density, a Marker of Breast Cancer Rlisk

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by University of Wisconsin, Madison.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Wisconsin, Madison
ClinicalTrials.gov Identifier:
NCT00839696
First received: February 5, 2009
Last updated: November 18, 2011
Last verified: November 2011
  Purpose

Mammographic density is sensitive to estorgen exposure and constitutes a strong intermediate maker of breast cancer risk. We hypothesize that women with higher serum xenoestrogen levels will have greater mammographic density.


Condition Phase
Breast Cancer Risk
Phase 4

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Total Xonoestrogen Body Burden in Relation to Mammographic Density, a Marker of Breast Cancer Risk

Resource links provided by NLM:


Further study details as provided by University of Wisconsin, Madison:

Primary Outcome Measures:
  • Characterize the distribution of total xenoestrogen burden and identify important source of xenoestrogen exposure among a clinic-based sample of postmenopausal women. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Evaluate the association of total xenoestorgen exposure with mammographic density. [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Serum Xenoestrogen


Estimated Enrollment: 270
Study Start Date: July 2008
Estimated Study Completion Date: February 2012
Primary Completion Date: February 2010 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   55 Years to 70 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects recruited from screening mammography population

Criteria

Inclusion Criteria:

  • 55-70 years of age, Post menopausal

Exclusion Criteria:

  • If they have ever used hormone replacment therapy or have ever used Tamoxifen or Raloxifene, Diag. with breast cancer have had breast implants or have had a mastectomy/
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00839696

Locations
United States, Wisconsin
University of Wisconsin Hospital
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
Principal Investigator: Amy Trentham Dietz, PhD Associate Professor- Population Health Sciences, UW School of Medicine and Public Health
  More Information

No publications provided

Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT00839696     History of Changes
Other Study ID Numbers: CC07104
Study First Received: February 5, 2009
Last Updated: November 18, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by University of Wisconsin, Madison:
Breast
Estrogens
Mammography

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on October 01, 2014