Ignite Creation Date:
2025-12-24 @ 4:59 PM
Ignite Modification Date:
2025-12-27 @ 8:31 AM
Study NCT ID:
NCT00131950
Status:
COMPLETED
Last Update Posted:
2013-07-10
First Post:
2005-08-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Lifestyle Factors and Hormone Function on Breast Density in Healthy Hispanic Women Who Are Undergoing Mammography for Breast Cancer Screening
Sponsor:
National Cancer Institute (NCI)
Organization:
Study Overview
Official Title:
Chicago Breast Health Project, Phase II
Status:
COMPLETED
Status Verified Date:
2005-10
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: Lifestyle factors, such as physical activity, diet, and obesity, and hormone function may affect breast density. Screening tests, such as mammography, may help doctors find tumor cells early and plan better treatment for breast cancer.
PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function on breast density in healthy Hispanic women who are undergoing mammography for breast cancer screening.
PURPOSE: This clinical trial is studying the effect of lifestyle factors and hormone function on breast density in healthy Hispanic women who are undergoing mammography for breast cancer screening.
Detailed Description:
OBJECTIVES:
* Correlate physical activity, diet, and obesity, as measured by body mass index and waist circumference, with percent breast density and the absolute estimate of total dense breast area in healthy Hispanic women undergoing screening mammography.
* Correlate fasting serum insulin growth factor (IGF)-1 and the molar ratio of IGF-1 to IGF binding protein-3 with breast density in participants undergoing screening mammography.
* Correlate insulin concentration and insulin resistance with breast density in participants undergoing screening mammography.
OUTLINE: This is a multicenter study.
Participants undergo blood collection and physical examination. Participants also complete breast cancer risk factor, food frequency, and physical activity questionnaires and receive breast health and physical activity education. Participants then undergo a digital screening mammogram. Participants are notified of mammogram results.
PROJECTED ACCRUAL: A total of 114 participants will be accrued for this study.
* Correlate physical activity, diet, and obesity, as measured by body mass index and waist circumference, with percent breast density and the absolute estimate of total dense breast area in healthy Hispanic women undergoing screening mammography.
* Correlate fasting serum insulin growth factor (IGF)-1 and the molar ratio of IGF-1 to IGF binding protein-3 with breast density in participants undergoing screening mammography.
* Correlate insulin concentration and insulin resistance with breast density in participants undergoing screening mammography.
OUTLINE: This is a multicenter study.
Participants undergo blood collection and physical examination. Participants also complete breast cancer risk factor, food frequency, and physical activity questionnaires and receive breast health and physical activity education. Participants then undergo a digital screening mammogram. Participants are notified of mammogram results.
PROJECTED ACCRUAL: A total of 114 participants will be accrued for this study.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| CDR0000437805 | REGISTRY | PDQ (Physician Data Query) | View |