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Genetic and Protein Profiling in Normal and Cancerous Breast Tissue

NCT00083733 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 216

Last updated 2017-07-02

No results posted yet for this study

Summary

This study will collect, analyze, and compare genes and proteins in normal breast tissue with those in various tissues from women with breast cancer to look for changes that are unique to breast cancer cells. Information about these differences may lead to more effective breast cancer treatments with fewer side effects. The study has the following objectives:

* To define the molecular (genetic and protein) profile of normal breast tissue from pre- and post-menopausal women of different ages and who have had varying numbers of children (or no children), and who are in different phases of the menstrual cycle
* To define the molecular profile of primary breast tumors and tumors that have metastasized (spread) beyond the primary site
* To characterize breast cancer stem cells and establish cell lines from the pleural fluid (fluid around the lungs) of women with metastatic breast cancer. (A cell line is a collection of cells that are grown in the laboratory from an original tissue specimen.)

The following women may be eligible for this study:

* Women who are undergoing cosmetic breast surgery that requires removal of some breast tissue (e.g., breast reduction surgery)
* Women 18 years of age or older who are undergoing a biopsy or other surgical procedure to sample or remove a known or suspected primary or metastatic breast tumor
* Women 18 years of age or older who are undergoing pleurocentesis, a procedure to remove fluid from around the lung that is suspected or known to be caused by spread of breast cancer

Participants undergo the required procedure (e.g., surgery, biopsy, or pleurocentesis) and provide information that may include the following:

* Age, race/ethnicity
* Age at first menstrual period (menarche)
* Age at first pregnancy and age when the first child was born
* Age at menopause
* Information about primary breast cancer
* Family history of breast cancer
* Information on previous breast biopsies, if any, and hormones taken (birth control pills or hormone replacement therapy), if any
* Copy of pathology report from procedure (surgery, biopsy, or pleurocentesis)

Conditions

  • Breast Neoplasms

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-05-27
Completion
2010-11-17

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00083733 on ClinicalTrials.gov