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

Breast Cancer Clinical Trial

Official title:

Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00445445
• Other study ID #: CASE1105
• Secondary ID: P30CA043703CASE1
• Status: Completed
• Start date: January 10, 2007
• Est. completion date: July 21, 2014

Study information

• Verified date: February 2020
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.

PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

Description:

OBJECTIVES:

• Characterize each woman's individual mammographic density (MD) longitudinal change trajectory in women with breast cancer and in healthy female participants to assess within-individual MD longitudinal change and breast cancer risk.

• Examine whether these patients or healthy participants manifest different patterns of within-individual change in MD and evaluate predictors of across-individual differences.

• Determine whether the developmental profile of MD differs systematically between these patients and healthy participants.

OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy participants are frequency-matched by age (± 2 years) and ethnicity.

• 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.

PROJECTED ACCRUAL: A total of 1500 patients and 1500 healthy participants will be accrued for this study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2201
• Est. completion date: July 21, 2014
• Est. primary completion date: July 21, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system

• Have at least 3 screening mammograms since 1994

• for cases, diagnosis with breast cancer between 2004-2006

Exclusion criteria:

• having had irregular screening (less than 3 mammorgrams since 1994)

• Having breast implants

• Known carriers of BRCA1/BRCA2 genes

• Unable to give written consent

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• physiologic testing
Urine samples will be assessed for levels of bisphenol-A
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
United States	University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center	Cleveland	Ohio
United States	UH-Monarch	Mayfield Heights	Ohio
United States	UH-LUICC	Mentor	Ohio
United States	UH-Southwest	Middleburg Heights	Ohio
United States	UH-Chagrin Highlands Orange Village Ohio 44122	Orange Village	Ohio
United States	UH-Firelands	Sandusky	Ohio
United States	UH-Green Road	South Euclid	Ohio
United States	UH-Westlake	Westlake	Ohio

Sponsors (2)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Within-individual mammographic density (MD) longitudinal change and breast cancer risk		cancer cases diagnosed within the last 3 years (2004-2006).
Primary	Patterns of within-individual longitudinal change in MD		cancer cases diagnosed within the last 3 years (2004-2006)
Primary	Predictors of across-individual differences in MD change		cancer cases diagnosed within the last 3 years (2004-2006)