Total Xenoestrogen Body Burden in Relation to Mammographi... | NCT00839696

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

NCT00839696

Sponsor

University of Wisconsin, Madison

Status

Completed

Last Update Posted

Nov 19, 2019Actual

Enrollment

270Actual

Phase

Not provided

Conditions

Breast Cancer Risk

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description
2008-1013	Other Identifier	Institutional Review Board
A538500	Other Identifier	UW Madison
SMPH/POP HEALTH SCI	Other Identifier	UW Madison

Status Module

Record Verification Date

Dec 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Apr 2010Actual

First Submitted Date

Feb 5, 2009

First Submission Date that Met QC Criteria

Feb 5, 2009

First Posted Date

Feb 9, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 15, 2019

Last Update Posted Date

Nov 19, 2019Actual

Name	Class
United States Department of Defense	FED

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

270Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Evaluate the association of total xenoestorgen exposure with mammographic density.		1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility 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/

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

55 Years

Maximum Age

70 Years

Standard Ages

AdultOlder Adult

Study Population

Subjects recruited from screening mammography population

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Amy Trentham Dietz, PhD	Associate Professor- Population Health Sciences, UW School of Medicine and Public Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Wisconsin Hospital		Madison	Wisconsin	53792	United States