Clinical trial NCT00445445: Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
Official title: Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: 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
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2007-03-09
Enrollment: 2201
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: OTHER
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.

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Within-individual mammographic density (MD) longitudinal change and breast cancer risk
timeFrame: cancer cases diagnosed within the last 3 years (2004-2006).
measure: Patterns of within-individual longitudinal change in MD
timeFrame: cancer cases diagnosed within the last 3 years (2004-2006)
measure: Predictors of across-individual differences in MD change
timeFrame: cancer cases diagnosed within the last 3 years (2004-2006)
Secondary outcomes:
Other outcomes:
Locations:
city: Cleveland
country: United States
facility: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
state: Ohio
city: Mayfield Heights
country: United States
facility: UH-Monarch
state: Ohio
city: Mentor
country: United States
facility: UH-LUICC
state: Ohio
city: Middleburg Heights
country: United States
facility: UH-Southwest
state: Ohio
city: Orange Village
country: United States
facility: UH-Chagrin Highlands Orange Village Ohio 44122
state: Ohio
city: Sandusky
country: United States
facility: UH-Firelands
state: Ohio
city: South Euclid
country: United States
facility: UH-Green Road
state: Ohio
city: Westlake
country: United States
facility: UH-Westlake
state: Ohio
Study officials:
affiliation: University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center
name: Cheryl Thompson, PhD
role: PRINCIPAL_INVESTIGATOR
References: