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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Case Comprehensive Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Case Comprehensive Cancer Center
ClinicalTrials.gov Identifier:
NCT00445445
First received: March 7, 2007
Last updated: March 6, 2014
Last verified: March 2014

March 7, 2007
March 6, 2014
January 2007
September 2014   (final data collection date for primary outcome measure)
  • 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 ]
Not Provided
Complete list of historical versions of study NCT00445445 on ClinicalTrials.gov Archive Site
Not Provided
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Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

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.

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 1500 patients and 1500 healthy participants will be accrued for this study.

Observational
Observational Model: Case Control
Not Provided
Retention:   Samples With DNA
Description:

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.

Probability Sample

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.

Breast Cancer
  • 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.
  • Patients
    Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
    Interventions:
    • Other: physiologic testing
    • Other: screening questionnaire administration
    • Procedure: breast imaging study
    • Procedure: radiomammography
    • Procedure: study of high risk factors
  • 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.
    Interventions:
    • Other: physiologic testing
    • Other: screening questionnaire administration
    • Procedure: breast imaging study
    • Procedure: radiomammography
    • Procedure: study of high risk factors
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
3000
Not Provided
September 2014   (final data collection date for primary outcome measure)

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
Female
50 Years and older
Yes
Contact: Li Li, MD, PhD 216-844-3944 li.li@uhhospitals.org
United States
 
NCT00445445
CASE1105, P30CA043703, CASE1105
Yes
Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
National Cancer Institute (NCI)
Principal Investigator: Li Li, MD, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Principal Investigator: Cheryl Thompson, PhD Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
Case Comprehensive Cancer Center
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP