Nuclear Morphology of Breast Cells in Ductal Lavage

This study has been completed.
Sponsor:
Collaborator:
Wayne State University
Information provided by (Responsible Party):
Zora Djuric, University of Michigan
ClinicalTrials.gov Identifier:
NCT00259597
First received: November 28, 2005
Last updated: December 19, 2012
Last verified: November 2008
  Purpose

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 Intervention
Benign Breast Disease
Procedure: breast ductal lavage

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Morphometry of Breast Cells in Ductal Lavage

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Enrollment: 57
Study Start Date: June 2004
Study Completion Date: June 2007
Primary Completion Date: June 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: breast ductal lavage
    breast ductal lavage and nipple aspiration done once
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

women with a previous biopsy of proliferative breast disease

Criteria

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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00259597

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

Publications:
Responsible Party: Zora Djuric, Research Professor, University of Michigan
ClinicalTrials.gov Identifier: NCT00259597     History of Changes
Other Study ID Numbers: Morphology, 1R21 CA100575-01A1
Study First Received: November 28, 2005
Last Updated: December 19, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on September 18, 2014