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

NCT00429988 | Completed

• 2 other identifiers: CDR0000378088UCSF-TEMP01
• Study Type: observational
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

breast cancer

Outcome Measures

Primary Outcomes (1)

• Average number of atypical cells per ductal lavage sample

Secondary Outcomes (4)

• Assay techniques development for nipple aspirate fluid and ductal lavage fluid analysis

• Specific and global protein signature analysis of nipple aspirate

• Replicability of markers in serial assays

• Percentage of participants with atypia on ductal lavage in which ductal lesions can be identified using ductoscopy

Interventions

fluorescence in situ hybridization GENETIC

polymerase chain reaction GENETIC

proteomic profiling GENETIC

cytology specimen collection procedure OTHER

immunohistochemistry staining method OTHER

breast duct lavage PROCEDURE

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women at increased risk for breast cancer

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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• University of California, San Francisco: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UCSF Comprehensive Cancer Center

San Francisco, California, 94115, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

In Situ Hybridization, Fluorescence; Polymerase Chain Reaction; Immunohistochemistry

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

In Situ Hybridization; Staining and Labeling; Histocytological Preparation Techniques; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Histological Techniques; Investigative Techniques; Cytogenetic Analysis; Genetic Techniques; Nucleic Acid Hybridization; Nucleic Acid Amplification Techniques; Histocytochemistry; Immunologic Techniques

Study Officials

• Laura J. Esserman, MD, MBA

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2007
• First Posted: February 1, 2007
• Study Start: August 1, 2002
• Primary Completion: June 1, 2004
• Study Completion: June 1, 2004
• Last Updated: September 26, 2012

Record last verified: 2012-09

Locations

US (1)