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

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

physiologic testing

study of socioeconomic and demographic variables

breast imaging study

study of high risk factors

About this trial

This is an interventional screening trial for Breast Cancer focused on measuring breast cancer

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00131950

First Posted

August 16, 2005

Last Updated

July 9, 2013

Sponsor

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00131950

Brief Title

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

Official Title

Chicago Breast Health Project, Phase II

Study Type

Interventional

2. Study Status

Record Verification Date

October 2005

Overall Recruitment Status

Completed

Study Start Date

August 2003 (undefined)

Primary Completion Date

undefined (undefined)

Study Completion Date

November 2005 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

National Cancer Institute (NCI)

4. Oversight

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

breast cancer

7. Study Design

Primary Purpose

Screening

Study Phase

Not Applicable

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

physiologic testing

Intervention Type

Other

Intervention Name(s)

study of socioeconomic and demographic variables

Intervention Type

Procedure

Intervention Name(s)

breast imaging study

Intervention Type

Procedure

Intervention Name(s)

study of high risk factors

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Susan M. Gapstur

Organizational Affiliation

Robert H. Lurie Cancer Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Robert H. Lurie Comprehensive Cancer Center at Northwestern University

City

Chicago

State/Province

Illinois

ZIP/Postal Code

60611

Country

United States

12. IPD Sharing Statement

Learn more about this trial

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

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