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:
Information provided by:
National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:
NCT00131950
First received: August 16, 2005
Last updated: July 9, 2013
Last verified: October 2005

August 16, 2005
July 9, 2013
August 2003
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Complete list of historical versions of study NCT00131950 on ClinicalTrials.gov Archive Site
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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
Chicago Breast Health Project, Phase II

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.

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.

Interventional
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Primary Purpose: Screening
Breast Cancer
  • Other: physiologic testing
  • Other: study of socioeconomic and demographic variables
  • Procedure: breast imaging study
  • Procedure: study of high risk factors
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
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November 2005
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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
Female
40 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00131950
NU-0212-005, CDR0000437805
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National Cancer Institute (NCI)
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Principal Investigator: Susan M. Gapstur Robert H. Lurie Cancer Center
National Cancer Institute (NCI)
October 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP