Ignite Creation Date:
2024-05-05 @ 5:22 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00445445
Status:
COMPLETED
Last Update Posted:
2020-02-11
First Post:
2007-03-07
Brief Title:
Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women
Sponsor:
Case Comprehensive Cancer Center
Organization:
Case Comprehensive Cancer Center
Study Overview
Official Title:
Longitudinal Changes in Mammographic Density and Risk of Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 womans 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
Characterize each womans 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| CASE1105 | OTHER | Case Comprehensive Cancer Center | httpsreporternihgovquickSearchP30CA043703 |
| P30CA043703 | NIH | None | None |