Benign Breast Disease Clinical Trial
Official title:
Morphometry of Breast Cells in Ductal Lavage
Verified date | November 2008 |
Source | University of Michigan |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Observational |
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.
Status | Completed |
Enrollment | 57 |
Est. completion date | June 2007 |
Est. primary completion date | June 2007 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
United States | Karmanos Cancer Institute | Detroit | Michigan |
Lead Sponsor | Collaborator |
---|---|
University of Michigan | Wayne State University |
United States,
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.2009.07.00 — View Citation
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT00842465 -
Prolactin Receptor and Breast Diseases
|
N/A | |
Enrolling by invitation |
NCT05836246 -
The Development of Quantitative Ultrasound Imaging Software Platform
|
||
Recruiting |
NCT06255808 -
Development of Assist Tool for Breast Examination Using the Principle of Ultrasonic Sensor
|
||
Recruiting |
NCT04127422 -
Risk Factors for Benign Breast Disease
|
||
Completed |
NCT04131972 -
REGENERA Implant in Excised Non-Malignant Breast Lesions
|
N/A | |
Completed |
NCT01116869 -
China CellSearch Study
|
||
Completed |
NCT01160510 -
Genetics of Mammographic Appearances and Patterns (The GenMap Study)
|
||
Recruiting |
NCT05364138 -
Evaluating Scaleup of an Adapted Breast Cancer Early Diagnosis Program in Rwanda
|
||
Active, not recruiting |
NCT02239874 -
VITamin D and OmegA-3 TriaL: Effects on Mammographic Density and Breast Tissue
|
N/A | |
Completed |
NCT04258085 -
Promoting Earlier Detection of Breast Cancer in Rwanda: Scaleup in the National Health Care System
|
||
Recruiting |
NCT06264934 -
An Investigation Into Dielectric Assessment of Permittivity and Conductivity in Human Using a Novel Electrical Capacitance Tomography Scanner
|
||
Completed |
NCT00999921 -
Effects of Tamoxifen in Premenopausal Women With Benign Breast Disease Not at High-Risk of Developing Breast Cancer
|
Phase 4 | |
Enrolling by invitation |
NCT05857111 -
Effectiveness Validation of CELBREA® in Symptomatic Women or With Diagnostic Doubt of Breast Pathology (DETECT-BH)
|
||
Completed |
NCT04744766 -
Central Mammary Duct Excision; How to Improve the Outcome?
|
N/A | |
Recruiting |
NCT04585074 -
Prospective Study of MAstectomy With Reconstruction Including Robot Endoscopic Surgery
|
||
Recruiting |
NCT01937039 -
Johns Hopkins Breast Cancer Program Longitudinal Repository
|