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

• ClinicalTrials.gov Identifier: NCT00445445
• Recruitment Status: Completed
• First Posted: March 9, 2007
• Last Update Posted: February 11, 2020
• Sponsor: Case Comprehensive Cancer Center
• Collaborator: National Cancer Institute (NCI)
• Information provided by (Responsible Party): Case Comprehensive Cancer Center

Study Description

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.

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

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.

Study Design

• Study Type: Observational
• Actual Enrollment: 2201 participants
• Observational Model: Case-Control
• Time Perspective: Other
• Official Title: Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
• Actual Study Start Date: January 10, 2007
• Actual Primary Completion Date: July 21, 2014
• Actual Study Completion Date: July 21, 2014

Groups and Cohorts

Group/Cohort	Intervention/treatment
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.

Outcome Measures

Primary Outcome Measures :

1. Within-individual mammographic density (MD) longitudinal change and breast cancer risk [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006). ]
2. Patterns of within-individual longitudinal change in MD [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006) ]
3. Predictors of across-individual differences in MD change [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006) ]

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.

Eligibility Criteria

• Ages Eligible for Study: 40 Years and older (Adult, Older Adult)
• Sexes 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

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

Contacts and Locations

Locations

United States, Ohio

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

Cleveland, Ohio, United States, 44106-5065

UH-Monarch

Mayfield Heights, Ohio, United States, 44124

UH-LUICC

Mentor, Ohio, United States, 44060

UH-Southwest

Middleburg Heights, Ohio, United States, 44130

UH-Chagrin Highlands Orange Village Ohio 44122

Orange Village, Ohio, United States, 44122

UH-Firelands

Sandusky, Ohio, United States, 44870

UH-Green Road

South Euclid, Ohio, United States, 44121

UH-Westlake

Westlake, Ohio, United States, 44145

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

• Principal Investigator: Cheryl Thompson, PhD; University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center

More Information

• Responsible Party: Case Comprehensive Cancer Center
• ClinicalTrials.gov Identifier: NCT00445445
• Other Study ID Numbers: CASE1105; P30CA043703 ( U.S. NIH Grant/Contract ); CASE1105 ( Other Identifier: Case Comprehensive Cancer Center )
• First Posted: March 9, 2007
• Last Update Posted: February 11, 2020
• Last Verified: February 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

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