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Sponsored by: |
National Cancer Institute (NCI) |
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Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00070460 |
RATIONALE: Diagnostic procedures, such as breast duct lavage and breast duct endoscopy, may help doctors find tumor cells early and plan better treatment for breast cancer. Studying the pattern of gene expression in breast duct cells from patients with breast cancer and from healthy participants may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.
PURPOSE: This clinical trial is studying breast duct lavage, breast duct endoscopy, and gene expression profiling to look for changes in breast duct cells in women with breast cancer compared with healthy women who are and are not at high risk for breast cancer.
Condition | Intervention |
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Breast Cancer |
Procedure: breast duct lavage Procedure: breast imaging study Procedure: comparative genomic hybridization Procedure: cytology specimen collection procedure Procedure: endoscopic biopsy Procedure: gene expression profiling Procedure: proteomic profiling |
Study Type: | Interventional |
Study Design: | Diagnostic, Open Label |
Official Title: | Characterization Of High Risk Breast Duct Epithelium By Cytology, Breast Duct Endoscopy, And cDNA Gene Expression Profile |
Estimated Enrollment: | 110 |
Study Start Date: | January 2002 |
OBJECTIVES:
Primary
Secondary
OUTLINE: Participants are stratified according to menopausal status (premenopausal vs postmenopausal).
Participants undergo breast duct lavage (in the contralateral breast for breast cancer patients and in either normal breast for healthy volunteers and high-risk subjects) and breast duct endoscopy.
Participants found to have cytologic atypia may undergo MRI and/or galactography to further localize or excise the abnormality. Participants with a cytologic atypia not suspected for malignancy undergo a follow-up lavage and endoscopy in 3-6 months.
Gene expression profiles, comparative genomic hybridization, and proteomic profiles are conducted on lavage cells.
PROJECTED ACCRUAL: A total of 110 participants (70 breast cancer patients and high-risk subjects [35 per stratum] and 40 healthy volunteers [20 per stratum]) will be accrued for this study.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
DISEASE CHARACTERISTICS:
Breast cancer and high-risk subjects
Diagnosis of unilateral breast cancer of epithelial origin (breast cancer patients)
Contralateral breast must be free of any suspicious areas by physical examination and mammogram AND without prior invasive ductal carcinoma or ductal carcinoma in situ
Healthy volunteers
PATIENT CHARACTERISTICS:
Age
Sex
Menopausal status
Premenopausal or postmenopausal
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Other
PRIOR CONCURRENT THERAPY:
Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
United States, Maryland | |
NCI - Surgery Branch | Recruiting |
Bethesda, Maryland, United States, 20892 | |
Contact: David N. Danforth, MD, MS 301-496-1533 david_danforth@nih.gov | |
Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office | Recruiting |
Bethesda, Maryland, United States, 20892-1182 | |
Contact: Contact Person 888-NCI-1937 |
Study Chair: | David N. Danforth, MD, MS | NCI - Surgery Branch |
Study ID Numbers: | CDR0000334479, NCI-02-C-0077 |
Study First Received: | October 3, 2003 |
Last Updated: | December 11, 2008 |
ClinicalTrials.gov Identifier: | NCT00070460 |
Health Authority: | Unspecified |
recurrent breast cancer stage I breast cancer stage II breast cancer stage IIIA breast cancer |
stage IIIB breast cancer stage IIIC breast cancer stage IV breast cancer |
Skin Diseases Breast Neoplasms Healthy Breast Diseases Recurrence |
Neoplasms Neoplasms by Site |