Nuclear Morphology of Breast Cells in Ductal Lavage

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. Identifier: NCT00259597
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : December 20, 2012
Wayne State University
Information provided by (Responsible Party):
Zora Djuric, University of Michigan

Brief Summary:
Breast nipple aspirate fluids (NAF) are useful for non-invasive monitoring of the breast. NAF has been shown to exhibit large inter-individual differences in lipid peroxidation. Unfortunately, the yield of epithelial cells in NAF is low. More recently, breast ductal lavage has been approved for clinical use. Nuclear morphologic features of breast biopsies have been shown previously to have prognostic value for breast cancer risk. In women without cancer, there may be subtle changes in the breast epithelial cells that can only be defined with computer-assisted measurements. The subjects selected for this study will be 98 women with biopsy-confirmed proliferative breast disease. These women are at slightly increased breast cancer risk, and exhibit higher mean levels of cholesterol and cholesterol oxides in NAF than women with non-proliferative histology in the breast. Levels of 8-isoprostane, cholesterol, fatty acids, fat-soluble micronutrients and 2,6-cyclolycopene-4,5-diol will be quantified in breast NAF that is obtained before breast lavage. These measures were chosen based on their potential relationship to dietary intakes and to oxidative stress, which is relevant to the application of these methods to dietary prevention studies.The investigators will characterize the morphology of breast epithelial cells from lavage using quantitative image cytometry to capture nuclear and cellular area, diameter, roundness, perimeter, and nuclear:cytoplasmic area ratio. Correlations will be evaluated between the measured morphologic features and each analyte in the NAF. The impact of various clinical, demographic and dietary factors on cellular morphology will also be explored. This study will help establish the feasibility of using these measures as endpoints in dietary intervention studies and will generate hypotheses that should be tested in larger studies. Such measures also should be applicable to molecular epidemiological investigations that seek to examine the impact of certain gene polymorphisms and environmental exposures on biomarkers of cancer risk.

Condition or disease Intervention/treatment
Benign Breast Disease Procedure: breast ductal lavage

  Show Detailed Description

Study Type : Observational
Actual Enrollment : 57 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphometry of Breast Cells in Ductal Lavage
Study Start Date : June 2004
Actual Primary Completion Date : June 2007
Actual Study Completion Date : June 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Diseases

Intervention Details:
  • Procedure: breast ductal lavage
    breast ductal lavage and nipple aspiration done once

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
women with a previous biopsy of proliferative breast disease

Inclusion Criteria:

  • Age 18 and older
  • A diagnosis of proliferative breast disease
  • At least 1 month post biopsy
  • At least 3 months post any therapy such as tamoxifen
  • Good general health
  • Sign Consent Form.

Exclusion Criteria:

  • Pregnant or lactating (lactation must have stopped at least 3 months prior)
  • Taking coumadin
  • Any diseases including cardiovascular, high blood pressure and diabetes

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 identifier (NCT number): NCT00259597

United States, Michigan
Karmanos Cancer Institute
Detroit, Michigan, United States, 48201
Sponsors and Collaborators
University of Michigan
Wayne State University
Principal Investigator: Zora Djuric, PhD University of Michigan

Publications of Results:
Responsible Party: Zora Djuric, Research Professor, University of Michigan Identifier: NCT00259597     History of Changes
Other Study ID Numbers: Morphology
1R21CA100575-01A1 ( U.S. NIH Grant/Contract )
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: December 20, 2012
Last Verified: November 2008

Keywords provided by Zora Djuric, University of Michigan:
nuclear morphology
image analysis
lipid peroxidation
proliferative breast disease

Additional relevant MeSH terms:
Breast Diseases
Fibrocystic Breast Disease
Skin Diseases