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Longitudinal Changes in Mammographic Density and Risk of Breast Cancer


N/A
50 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Longitudinal Changes in Mammographic Density and Risk of Breast Cancer


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.

Inclusion 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

Type of Study:

Observational

Study Design:

Observational Model: Case Control

Outcome Measure:

Within-individual mammographic density (MD) longitudinal change and breast cancer risk

Outcome Time Frame:

cancer cases diagnosed within the last 3 years (2004-2006).

Safety Issue:

No

Principal Investigator

Li Li, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

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

Authority:

United States: Institutional Review Board

Study ID:

CASE1105

NCT ID:

NCT00445445

Start Date:

January 2007

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer CenterCleveland, Ohio  44106-5065
UH-MonarchMayfield Heights, Ohio  44124
UH-LUICCMentor, Ohio  44060
UH-SouthwestMiddleburgh Heights, Ohio  44130
UH-Green RoadSouth Euclid, Ohio  44121
UH-WestlakeWestlake, Ohio  44145
UH-Chagrin Highlands Orange Village Ohio 44122Orange Village, Ohio  44122
UH-FirelandsSandusky, Ohio  44870