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

Tracking Information

First Received Date ^ICMJE

February 5, 2009

Last Updated Date

November 18, 2011

Start Date ^ICMJE

July 2008

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT00839696 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

Total Xonoestrogen Body Burden in Relation to Mammographic Density, a Marker of Breast Cancer Risk

Brief Summary

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Observational

Study Design ^ICMJE

Observational Model: Cohort
Time Perspective: Prospective

Target Follow-Up Duration

Not Provided

Biospecimen

Retention: Samples Without DNA

Description:

Serum Xenoestrogen

Sampling Method

Probability Sample

Study Population

Subjects recruited from screening mammography population

Condition ^ICMJE

Breast Cancer Risk

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

270

Estimated Completion Date

February 2012

Primary Completion Date

February 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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/

Gender

Female

Ages

55 Years to 70 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00839696

Other Study ID Numbers ^ICMJE

CC07104

Has Data Monitoring Committee

Responsible Party

University of Wisconsin, Madison

Study Sponsor ^ICMJE

University of Wisconsin, Madison

Collaborators ^ICMJE

Department of Defense

Investigators ^ICMJE

Principal Investigator:

Amy Trentham Dietz, PhD

Associate Professor- Population Health Sciences, UW School of Medicine and Public Health

Information Provided By

University of Wisconsin, Madison

Verification Date

November 2011

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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