Effect of Lifestyle Factors and Hormone Function on Breast Density in Healthy Hispanic Women Who Are Undergoing Mammography for Breast Cancer Screening

Breast Cancer Clinical Trial

Official title:

Chicago Breast Health Project, Phase II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00131950
• Other study ID #: NU-0212-005
• Secondary ID: CDR0000437805
• Status: Completed
• Phase: N/A
• First received: August 16, 2005
• Last updated: July 9, 2013
• Start date: August 2003
• Est. completion date: November 2005

Study information

• Verified date: October 2005
• Source: National Cancer Institute (NCI)
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 0
• Est. completion date: November 2005
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Healthy Hispanic women

• Registered patient at the Erie Family Health Centers' West Town or Humboldt Park clinics

• No screening mammography within the past 12 months

• No abnormality on clinical breast exam

• No history of breast cancer

• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 40 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• Not specified

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• Not specified

Study Design

Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• physiologic testing

• study of socioeconomic and demographic variables

Procedure:
• breast imaging study

• study of high risk factors

Locations

Country	Name	City	State
United States	Robert H. Lurie Comprehensive Cancer Center at Northwestern University	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
National Cancer Institute (NCI)

Country where clinical trial is conducted

United States,