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Alternate Title
Basic Trial Information
Trial Description
     Purpose
     Eligibility
     Treatment/Intervention
Trial Contact Information
Related Information
Registry Information

Alternate Title

Study of Breast Duct Lavage, Breast Duct Endoscopy, and DNA Gene Expression Profiling in Women With Ipsilateral Breast Cancer Versus Healthy Women Who Are and Are Not at High Risk for Breast Cancer

Basic Trial Information

Phase Type Status Age Sponsor Protocol IDs No phase specified Biomarker/Laboratory analysis, Diagnostic, Screening Active Adult NCI NCI-02-C-0077 NCT00070460

Special Category: NIH Clinical Center trial

Trial Description

Purpose:

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.

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.

Eligibility:

Eligibility criteria include the following:

• Adult
• Not pregnant or lactating
• No breast implants
• Breast cancer in one breast only (patient)
• No previous surgery to ducts in the breast without cancer (patient)
• More than 3 months since chemotherapy (patient)
• No previous radiation therapy to the breast without cancer (patient)
• No cancer in either breast (healthy participant)
• No previous surgery to ducts in either breast (healthy participant)
• No previous radiation therapy to the chest (healthy participant)
• For more information about the eligibility criteria for this trial, refer to the Health Professional version.

Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Treatment/Intervention:

Participants will undergo breast duct lavage and breast duct endoscopy. Some participants may also undergo MRI and/or other imaging tests. Some participants may undergo a second breast duct lavage and breast duct endoscopy 3-6 months later. Breast duct cells collected during breast duct lavage will be studied in the laboratory.

Important:

For more details about this trial, refer to the Health Professional version of the trial summary.

If you are interested in participating in a clinical trial, contact your doctor for a referral or call a trial contact person listed below. You may see the same contact person listed at more than one site, however, if you call the number listed you can ask to speak to the study coordinator or person involved with the specific trial you are interested in. If you have questions about cancer or clinical trials, call the Cancer Information Service at 1-800-4-CANCER (1-800-422-6237). General information about clinical trials, including risks, benefits, and costs, can be found on NCI's Web site.

Trial Contact Information

Trial Lead Organizations

NCI - Center for Cancer Research

David Danforth, MD, MS, Protocol chair		Ph: 301-496-1533 Email: david_danforth@nih.gov

U.S.A.
Maryland
	Bethesda
	NCI - Surgery Branch
		David Danforth, MD, MS	Ph:  301-496-1533
			Email: david_danforth@nih.gov
	Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office
		Contact Person	Ph:  888-NCI-1937

Related Information

Web site for additional information

Registry Information
Official Title		Characterization Of High Risk Breast Duct Epithelium By Cytology, Breast Duct Endoscopy, And cDNA Gene Expression Profile
Trial Start Date		2002-01-01
Registered in ClinicalTrials.gov		NCT00070460
Date Submitted to PDQ		2003-08-25
Information Last Verified		2008-04-20