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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00131950
First Posted: August 19, 2005
Last Update Posted: July 10, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
National Cancer Institute (NCI)
  Purpose

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.


Condition Intervention
Breast Cancer Other: physiologic testing Other: study of socioeconomic and demographic variables Procedure: breast imaging study Procedure: study of high risk factors

Study Type: Interventional
Study Design: Primary Purpose: Screening
Official Title: Chicago Breast Health Project, Phase II

Resource links provided by NLM:


Further study details as provided by National Cancer Institute (NCI):

Study Start Date: August 2003
Study Completion Date: November 2005
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131950


Locations
United States, Illinois
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
National Cancer Institute (NCI)
Investigators
Principal Investigator: Susan M. Gapstur Robert H. Lurie Cancer Center
  More Information

ClinicalTrials.gov Identifier: NCT00131950     History of Changes
Other Study ID Numbers: NU-0212-005
CDR0000437805 ( Registry Identifier: PDQ (Physician Data Query) )
First Submitted: August 16, 2005
First Posted: August 19, 2005
Last Update Posted: July 10, 2013
Last Verified: October 2005

Keywords provided by National Cancer Institute (NCI):
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases