Effect of Lifestyle Factors and Hormone Function on Breas... | NCT00131950

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

NCT00131950

Sponsor

National Cancer Institute (NCI)

Status

Completed

Last Update Posted

Jul 10, 2013Estimated

Enrollment

Not provided

Phase

Not Applicable

Conditions

Breast Cancer

Interventions

physiologic testing
study of socioeconomic and demographic variables
breast imaging study
study of high risk factors

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

ID	Type	Description	Link
CDR0000437805	Registry Identifier	PDQ (Physician Data Query)

Status Module

Record Verification Date

Oct 2005

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2003

Primary Completion Date

Not provided

Completion Date

Nov 2005Actual

First Submitted Date

Aug 16, 2005

First Submission Date that Met QC Criteria

Aug 16, 2005

First Posted Date

Aug 19, 2005Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 9, 2013

Last Update Posted Date

Jul 10, 2013Estimated

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

ID	Term
D009371	Neoplasms by Site
D009369	Neoplasms
D001941	Breast Diseases
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases

Name	Type	Description	Arm Group Labels	Other Names
physiologic testing	Other
study of socioeconomic and demographic variables	Other
breast imaging study	Procedure
study of high risk factors	Procedure