Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

CompletedOBSERVATIONAL
Enrollment

2,201

Participants

Timeline

Start Date

January 10, 2007

Primary Completion Date

July 21, 2014

Study Completion Date

July 21, 2014

Conditions
Breast Cancer
Interventions
OTHER

physiologic testing

Urine samples will be assessed for levels of bisphenol-A

OTHER

screening questionnaire administration

Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.

PROCEDURE

breast imaging study

Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

PROCEDURE

radiomammography

Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis.

PROCEDURE

study of high risk factors

"* Questionnaire: Patients and healthy participants complete a self-administered questionnaire providing detailed information on breast cancer risk factors, including demographics, behavioral and lifestyle factors, reproductive history, family history of breast cancer, comorbidities, medication and hormone replacement therapy use, and breast cancer screening history. This information is then cross-validated with documented data abstracted from medical records to provide a longitudinal and historical framework for assessing individual risk.~* Mammographic density (MD) assessment: Patients and healthy participants are evaluated for patterns of longitudinal change in MD and subsequent breast cancer risk by retrospective review of screening mammograms performed prior to breast cancer diagnosis."

Trial Locations (8)

44060

UH-LUICC, Mentor

44121

UH-Green Road, South Euclid

44122

UH-Chagrin Highlands Orange Village Ohio 44122, Orange

44124

UH-Monarch, Mayfield Heights

44130

UH-Southwest, Middleburg Heights

44145

UH-Westlake, Westlake

44870

UH-Firelands, Sandusky

44106-5065

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center, Cleveland

All Listed Sponsors
collaborator

National Cancer Institute (NCI)

NIH

lead

Case Comprehensive Cancer Center

OTHER

NCT00445445 - Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women | Biotech Hunter | Biotech Hunter