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Study of Ductal Lavage in Women at High Risk for Breast Cancer

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ClinicalTrials.gov Identifier: NCT00429988
Recruitment Status : Completed
First Posted : February 1, 2007
Last Update Posted : September 26, 2012
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
University of California, San Francisco

Brief Summary:

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 or disease Intervention/treatment
Breast Cancer Genetic: fluorescence in situ hybridization Genetic: polymerase chain reaction Genetic: proteomic profiling Other: cytology specimen collection procedure Other: immunohistochemistry staining method Procedure: breast duct lavage

Detailed Description:

OBJECTIVES:

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.


Study Type : Observational
Actual Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ductal Lavage to Monitor and Treat High Risk Women
Study Start Date : August 2002
Primary Completion Date : June 2004
Study Completion Date : June 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources




Primary Outcome Measures :
  1. Average number of atypical cells per ductal lavage sample

Secondary Outcome Measures :
  1. Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis
  2. Specific and global protein signature analysis of nipple aspirate
  3. Replicability of markers in serial assays
  4. Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Women at increased risk for breast cancer
Criteria

DISEASE CHARACTERISTICS:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00429988


Locations
United States, California
UCSF Comprehensive Cancer Center
San Francisco, California, United States, 94115
Sponsors and Collaborators
University of California, San Francisco
National Cancer Institute (NCI)
Investigators
Principal Investigator: Laura J. Esserman, MD, MBA University of California, San Francisco

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT00429988     History of Changes
Other Study ID Numbers: CDR0000378088
UCSF-TEMP01
First Posted: February 1, 2007    Key Record Dates
Last Update Posted: September 26, 2012
Last Verified: September 2012

Keywords provided by University of California, San Francisco:
breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases