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NCT00259597 · ClinicalTrials.gov registry record
Nuclear Morphology of Breast Cells in Ductal Lavage
A clinical trial, sponsored by University of Michigan.
- Completed
- Registry status
- 57
- Enrollment target
NCT00259597 is a clinical trial that has completed, run by University of Michigan. The registered enrollment target is 57 participants.
The verdict
NCT00259597 has completed, sponsored by University of Michigan.
- COMPLETED
- Registry status
- 57 participants
- Enrollment target
Study 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
Interventions
- PROCEDURE breast ductal lavage
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 57 participants |
| Start Date | 2004-06 |
| Est. Completion | 2007-06 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00259597
The ClinicalTrials.gov registry entry for NCT00259597 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 57 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Michigan, which has 1,327 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which breast ductal lavage is the first listed.
NCT00259597 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00259597 about?
NCT00259597 is a clinical study titled "Nuclear Morphology of Breast Cells in Ductal Lavage". 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 clin...
What is the current status of trial NCT00259597?
This trial is currently completed. The enrollment target is 57 participants. The study started on 2004-06. Estimated completion is 2007-06.
What interventions are being tested in trial NCT00259597?
The interventions under investigation include: breast ductal lavage (PROCEDURE).
Who is sponsoring clinical trial NCT00259597?
This trial is sponsored by University of Michigan, which has 1,327 total clinical trials registered on ClinicalTrials.gov.
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