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Trial record 47 of 197 for:    (hispanic OR latina) AND (woman OR women OR female)

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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ClinicalTrials.gov Identifier: NCT00131950
Recruitment Status : Completed
First Posted : August 19, 2005
Last Update Posted : July 10, 2013
Sponsor:
Information provided by:
National Cancer Institute (NCI)

Tracking Information
First Submitted Date  ICMJE August 16, 2005
First Posted Date  ICMJE August 19, 2005
Last Update Posted Date July 10, 2013
Study Start Date  ICMJE August 2003
Primary Completion Date Not Provided
Current Primary Outcome Measures  ICMJE Not Provided
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT00131950 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Outcome Measures  ICMJE Not Provided
Original Other Outcome Measures  ICMJE Not Provided
 
Descriptive Information
Brief Title  ICMJE Effect of Lifestyle Factors and Hormone Function on Breast Density in Healthy Hispanic Women Who Are Undergoing Mammography for Breast Cancer Screening
Official Title  ICMJE Chicago Breast Health Project, Phase II
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.

Study Type  ICMJE Interventional
Study Phase Not Applicable
Study Design  ICMJE Primary Purpose: Screening
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Other: physiologic testing
  • Other: study of socioeconomic and demographic variables
  • Procedure: breast imaging study
  • Procedure: study of high risk factors
Study Arms Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Enrollment  ICMJE Not Provided
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date November 2005
Primary Completion Date Not Provided
Eligibility Criteria  ICMJE

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 40 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00131950
Other Study ID Numbers  ICMJE NU-0212-005
CDR0000437805 ( Registry Identifier: PDQ (Physician Data Query) )
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Not Provided
Study Sponsor  ICMJE National Cancer Institute (NCI)
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Susan M. Gapstur Robert H. Lurie Cancer Center
PRS Account National Cancer Institute (NCI)
Verification Date October 2005

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