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
  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:


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: September 2014 (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.

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 1500 patients and 1500 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Investigators
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
  More Information

Additional Information:
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: March 6, 2014
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 September 18, 2014