Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women - Full Text View

Purpose

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.

Condition	Intervention
Breast Cancer	Other: physiologic testing Other: screening questionnaire administration Procedure: breast imaging study Procedure: radiomammography Procedure: study of high risk factors

Study Type:	Observational
Study Design:	Observational Model: Case Control
Official Title:	Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography

U.S. FDA Resources

Further study details as provided by Case Comprehensive Cancer Center:

Primary Outcome Measures:

Within-individual mammographic density (MD) longitudinal change and breast cancer risk [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006). ] [ Designated as safety issue: No ]
Patterns of within-individual longitudinal change in MD [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006) ] [ Designated as safety issue: No ]
Predictors of across-individual differences in MD change [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006) ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Time perspective: Prospective and retrospective. Blood and urine samples will be processed in our lab and stored in a -80 degree freezer until needed. Urine samples will be assessed for levels of bisphenol-A and remaining samples of urine and blood will be stored for future projects.

Estimated Enrollment:	3000
Study Start Date:	January 2007
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
Patients Histologically confirmed breast cancer that was diagnosed between the years 2002-2004	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.
Healthy participants Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.	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.

Groups/Cohorts

Assigned Interventions

Patients

Histologically confirmed breast cancer that was diagnosed between the years 2002-2004

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.

Healthy participants

Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.

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.

Detailed Description:

OBJECTIVES:

Determine the 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.
Determine 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 350 patients and 350 healthy participants will be accrued for this study.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes
Sampling Method:	Probability Sample

Study Population

Breast cancer cases diagnosed after 1994 and equal number of frequency-matched (by age within 2 years and ethnicity) controls. Cases and eligible controls with at least 3 screening mammograms since 1994 will be recruited through the University Hospitals Breast Center, and primary care clinics within the University Hospitals Health System (UHHS). The restriction of 3 or more screening mammograms will allow us to adequately model the longitudinal change patterns.

Criteria

DISEASE CHARACTERISTICS:

Meets 1 of the following criteria:
- Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system AND meets the following criteria:
  - Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
    - Known tumor stage
- Healthy participant who is receiving routine medical care (e.g., screening mammograms) at the University Hospitals Health System
Underwent ≥ 4 prior screening mammograms at the Breast Center since 1994
No known carriers of BRCA1 or BRCA2 genes
Hormone receptor status:
- Known estrogen and/or progesterone receptor status

PATIENT CHARACTERISTICS:

Female
Menopausal status not specified
No breast implants

PRIOR CONCURRENT THERAPY:

Not currently taking tamoxifen citrate, raloxifene, or aromatase inhibitors

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445445

Contacts

Contact: Li Li, MD, PhD

216-844-3944

li.li@uhhospitals.org

Locations

United States, Ohio
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Li Li, MD 216-844-3944 li.li@uhhospitals.org
UH-Monarch	Recruiting
Mayfield Heights, Ohio, United States, 44124
UH-LUICC	Recruiting
Mentor, Ohio, United States, 44060
UH-Southwest	Recruiting
Middleburgh Heights, Ohio, United States, 44130
UH-Chagrin Highlands Orange Village Ohio 44122	Recruiting
Orange Village, Ohio, United States, 44122
UH-Firelands	Recruiting
Sandusky, Ohio, United States, 44870
UH-Green Road	Recruiting
South Euclid, Ohio, United States, 44121
UH-Westlake	Recruiting
Westlake, Ohio, United States, 44145

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:	Li Li, MD, PhD	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Principal Investigator:	Cheryl Thompson	Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:	NCT00445445 History of Changes
Other Study ID Numbers:	CASE1105, P30CA043703, CASE1105
Study First Received:	March 7, 2007
Last Updated:	February 6, 2013
Health Authority:	United States: Institutional Review Board

Keywords provided by Case Comprehensive Cancer Center:

stage I breast cancer
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

stage IIIC breast cancer
stage IV breast cancer
recurrent breast cancer
breast cancer in situ

Additional relevant MeSH terms:

Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on May 23, 2013