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NCT00028340 · ClinicalTrials.gov registry record
High-Risk Breast Duct Epithelium
A clinical trial, sponsored by National Cancer Institute (NCI).
- Completed
- Registry status
- 156
- Enrollment target
NCT00028340: Completed study, sponsored by National Cancer Institute (NCI).
NCT00028340 is a clinical trial that has completed, run by National Cancer Institute (NCI). The registered enrollment target is 156 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00028340 has completed, sponsored by National Cancer Institute (NCI).
- COMPLETED
- Registry status
- 156 participants
- Enrollment target
Study Summary
Background: * Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States. * The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant changes which occur in the transformed epithelium are not well understood, however several cytologic or histologic changes have been identified which are associated with an increased risk for breast cancer, including ductal or lobular hyperplasia, hyperplasia with atypia, and lobular or ductal carcinoma in situ. * The identification of cytological or histological abnormalities in breast epithelial cells is an important component of risk assessment. Objective: Primary objectives are: * To determine the incidence and nature of cytologic changes in ductal epithelial cells from the high-risk breast, in specimens collected by breast ductal lavage, and to determine if these cytologic findings are different from those of female normal volunteers not at increased risk for breast cancer. * To characterize by breast duct endoscopy, high risk breast ductal epithelium and architecture, and correlate these findings with the cytologic findings referenced in above bullet. * To determine what is the global gene expression pattern of high risk breast epithelial cells from the high risk breast, and does this differ from that of breast epithelial cells from female normal volunteersnot at increased risk for breast cancer. The gene expression profile will be determined by cDNA microarray and validated by RT-PCR. Eligibility: Eligibility for high risk individuals will include: * Women with a unilateral invasive or noninvasive (DCIS) breast cancer of epithelial origin. * Women without breast cancer, but with a Gail Index greater than 1.67 percent, or a cumulative lifetime risk greater than or equal to double the age- and race-matched general population risk. * Women known to be BRCA1/2 or
Primary Outcome
Using specimens collected by breast ductal lavage, and determine if these cytologic findings are different from those of normal women not at increased risk for breast cancer.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2003-02-20 |
| Est. Completion | 2022-12-16 |
What the finished NCT00028340 record still lists
NCT00028340 is an observational study that tracks outcomes without assigning an intervention. The registered 156 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 0 interventions.
NCT00028340 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT00028340 about?
NCT00028340 is a clinical study titled "High-Risk Breast Duct Epithelium". Background: * Breast cancer is the most common malignancy in women, occurring in over 230,000 women annually in the United States. * The vast majority of breast cancers originate in the single layer of epithelial cells that line the ductal/lobular system of the breast milk ducts. The premalignant c...
What is the current status of trial NCT00028340?
This trial is currently completed. The enrollment target is 156 participants. The study started on 2003-02-20. Estimated completion is 2022-12-16.
Who is sponsoring clinical trial NCT00028340?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
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