NCT00839696

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
270

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2008

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2008

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

February 5, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 9, 2009

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2010

Completed
Last Updated

November 19, 2019

Status Verified

December 1, 2014

Enrollment Period

11 months

First QC Date

February 5, 2009

Last Update Submit

November 15, 2019

Conditions

Breast Cancer Risk

Keywords

BreastEstrogensMammography

Outcome Measures

Primary Outcomes (1)

  • Characterize the distribution of total xenoestrogen burden and identify important source of xenoestrogen exposure among a clinic-based sample of postmenopausal women.

    1 year

Secondary Outcomes (1)

  • Evaluate the association of total xenoestorgen exposure with mammographic density.

    1 year

Eligibility Criteria

Age55 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Subjects recruited from screening mammography population

You may qualify if:

  • years of age, Post menopausal

You may not qualify if:

  • 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/

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin Hospital

Madison, Wisconsin, 53792, United States

Location

Related Links

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Xenoestrogen

Study Officials

  • Amy Trentham Dietz, PhD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 5, 2009

First Posted

February 9, 2009

Study Start

July 1, 2008

Primary Completion

June 1, 2009

Study Completion

April 1, 2010

Last Updated

November 19, 2019

Record last verified: 2014-12

Locations

US(1)