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

Alternate Title

Screening Study of Nipple Aspiration Fluid, Ductal Lavage, and Duct Endoscopy in Women at Moderate to High Risk of Developing Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
No phase specified	Biomarker/Laboratory analysis, Natural history/Epidemiology, Screening	Active	18 to 64	Other	RMNHS-2278 EU-20352, NCT00081003

Trial Description

Purpose:

Screening tests, such as nipple aspiration, ductal lavage, and breast duct endoscopy, may help doctors detect cancer cells early and plan more effective treatment for breast cancer.

This clinical trial is studying how well nipple aspiration, ductal lavage, and breast duct endoscopy work in detecting cancer cells in healthy women who are at moderate-to-high risk of developing breast cancer.

Eligibility:

Eligibility criteria include the following:

• 18-64 years old
• No inflammatory breast cancer
• 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 nipple aspiration either once a year for 3 years or every 1½ years for 4½ years. Some participants may also undergo ductal lavage and breast duct endoscopy to examine the duct lining and collect duct cells and tissue samples to be examined under a microscope for early signs of cancer. Participants will be evaluated once a year for 10 years.

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

Royal Marsden - London

Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng), Protocol chair		Ph: 44-20-7808-2783 Email: gerald.gui@rmh.nhs.uk

United Kingdom
England
	London
	Royal Marsden - London
		Gerald Gui, MD, MS, FRCS(Edin), FRCS(Eng)	Ph:  44-20-7808-2783
			Email: gerald.gui@rmh.nhs.uk

Registry Information
Official Title		The Intraduct Environment: A Novel Approach to Risk Assessment of Women With a Family History of Breast Cancer
Trial Start Date		2003-11-01
Registered in ClinicalTrials.gov		NCT00081003
Date Submitted to PDQ		2004-02-23
Information Last Verified		2005-12-05