Study of Ductal Lavage in Women at High Risk for Breast Cancer
NCT ID: NCT00429988
Last Updated: 2012-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
30 participants
OBSERVATIONAL
2002-08-31
2004-06-30
Brief Summary
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PURPOSE: This clinical trial is using ductal lavage to collect fluid from women at high risk for breast cancer.
Detailed Description
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Primary
* Determine the volume of atypical cells collected from ductal lavage in women at increased risk for breast cancer.
Secondary
* Determine assay techniques to analyze nipple aspirate fluid and ductal lavage fluid samples from these participants.
* Analyze the nipple aspirate fluid from these participants for specific and global protein signatures.
* Determine the replicability of markers in serial assays of these participants.
* Determine the percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy.
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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Interventions
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polymerase chain reaction
proteomic profiling
cytology specimen collection procedure
immunohistochemistry staining method
breast duct lavage
fluorescence in situ hybridization
Eligibility Criteria
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Inclusion Criteria
* High risk for breast cancer defined as 1 of the following:
* History of atypical hyperplasia or atypia found on biopsy, fine-needle aspiration, or ductal lavage
* Family history of cancer meeting at least 1 of the following criteria:
* Single relative with multiple primary cancers
* One or more relative under 40 years of age with breast cancer OR bilateral breast cancer
* Two or more relatives with ovarian cancer
* Two or more relatives with breast cancer and 1 is under 50 years of age
* One or more relative with breast cancer plus ≥ 1 relative with ovarian cancer
* Ashkenazi Jewish descent AND relative with breast cancer under 50 years of age OR ovarian cancer at any age
* BRCA1 and/or BRCA2 mutation
* Prior breast cancer in contralateral breast
* Gail risk \> 1.7%
* Spontaneous nipple discharge
* Serum estradiol \> 10 pmol/L
* Hormone receptor status:
* Not specified
PATIENT CHARACTERISTICS:
Age
* Over 18
Sex
* Female
Menopausal status
* Not specified
Performance status
* Not specified
Life expectancy
* Not specified
Hematopoietic
* Not specified
Hepatic
* Not specified
Renal
* Not specified
Other
* Able to obtain breast duct fluids
PRIOR CONCURRENT THERAPY:
Biologic therapy
* Not specified
Chemotherapy
* Not specified
Endocrine therapy
* More than 4 months since prior tamoxifen or raloxifene
Radiotherapy
* No prior radiotherapy to the breast
Surgery
* No prior incisional or excisional biopsy within 1.5 cm of nipple
Other
* No prior neoadjuvant therapy
18 Years
FEMALE
No
Sponsors
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National Cancer Institute (NCI)
NIH
University of California, San Francisco
OTHER
Responsible Party
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Principal Investigators
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Laura J. Esserman, MD, MBA
Role: PRINCIPAL_INVESTIGATOR
University of California, San Francisco
Locations
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UCSF Comprehensive Cancer Center
San Francisco, California, United States
Countries
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Other Identifiers
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UCSF-TEMP01
Identifier Type: -
Identifier Source: secondary_id
CDR0000378088
Identifier Type: -
Identifier Source: org_study_id