Nuclear Morphology of Breast Cells in Ductal Lavage

NCT00259597 | Completed DMC

• 2 other identifiers: Morphology1R21CA100575-01A1
• Study Type: observational
• Target: 57
• Locations: 1 country
• Sites: 1

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.

Conditions

Benign Breast Disease

Keywords

nuclear morphology; image analysis; lipid peroxidation; diet; proliferative breast disease

Interventions

breast ductal lavage PROCEDURE

breast ductal lavage and nipple aspiration done once

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

women with a previous biopsy of proliferative breast disease

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University of Michigan: lead
• Wayne State University: collaborator

Study Sites (1)

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Related Publications (1)

• Djuric Z, Edwards A, Madan S, Darga L, Ren J, Blake C, Koletsky M, Heilbrun LK. Obesity is associated with atypia in breast ductal lavage of women with proliferative breast disease. Cancer Epidemiol. 2009 Oct;33(3-4):242-8. doi: 10.1016/j.canep.2009.07.003. Epub 2009 Jul 28.

  PMID: 19683484 RESULT

MeSH Terms

Conditions

Cystic Fibrosis

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases

Study Officials

• Zora Djuric, PhD

  University of Michigan

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Professor

Study Record Dates

• First Submitted: November 28, 2005
• First Posted: November 29, 2005
• Study Start: June 1, 2004
• Primary Completion: June 1, 2007
• Study Completion: June 1, 2007
• Last Updated: December 20, 2012

Record last verified: 2008-11

Locations

US (1)