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Sponsors and Collaborators: |
UCSF Helen Diller Family Comprehensive Cancer Center National Cancer Institute (NCI) |
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00429988 |
RATIONALE: Collecting samples of fluid using ductal lavage and nipple aspiration from participants at high risk for breast cancer to study in the laboratory may help doctors learn more about changes that may occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.
Condition | Intervention |
Breast Cancer |
Procedure: breast duct lavage Procedure: cytology specimen collection procedure Procedure: diagnostic procedure Procedure: fluorescence in situ hybridization Procedure: immunohistochemistry staining method Procedure: polymerase chain reaction Procedure: proteomic profiling |
Genetics Home Reference related topics: | breast cancer |
MedlinePlus related topics: | Breast Cancer Cancer |
Study Type: | Interventional |
Study Design: | Diagnostic |
Official Title: | Ductal Lavage to Monitor and Treat High Risk Women |
Study Start Date: | August 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study.
Participants undergo nipple aspirate fluid and ductal lavage fluid collection. Fluid samples are analyzed using cytological analysis, immunohistochemistry, fluorescent in situ hybridization, or in situ polymerase chain reaction. Protein patterns are identified using mass spectrometry.
Participants found to have atypia undergo repeat lavage at 3-6 months and 1 year. Participants with normal fluid samples undergo repeat lavage at 1 year.
PROJECTED ACCRUAL: A total of 30 participants will accrued for this study within 2-3 months.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
High risk for breast cancer defined as 1 of the following:
Family history of cancer meeting at least 1 of the following criteria:
Hormone receptor status:
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
United States, California | |||||
UCSF Comprehensive Cancer Center | |||||
San Francisco, California, United States, 94115 |
UCSF Helen Diller Family Comprehensive Cancer Center |
National Cancer Institute (NCI) |
Principal Investigator: | Laura J. Esserman, MD, MBA | UCSF Helen Diller Family Comprehensive Cancer Center |
Clinical trial summary from the National Cancer Institute's PDQ® database 
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Study ID Numbers: | CDR0000378088, UCSF-TEMP01 |
First Received: | January 30, 2007 |
Last Updated: | December 25, 2007 |
ClinicalTrials.gov Identifier: | NCT00429988 |
Health Authority: | United States: Federal Government |
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