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

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Department of Defense
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
History of Changes
  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:

U.S. FDA Resources

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
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
Department of Defense
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 May 23, 2013