The Breast Duct: Pilot Study of Genomic Sequencing of Exfoliated Ductal Cells Obtained Through Endoscopy and Lavage

Completed

Conditions studied: Breast Cancer, Preneoplastic Conditions, Ductal Carcinoma in Situ

In brief

The objective of this study is to determine whether we can use minimally invasive techniques to gain access to exfoliated ductal epithelial cells for whole genome sequencing. 1. To examine women with nipple aspiration, ductoscopy and ductal lavage and collect exfoliated cells from two ducts per woman. 2. To collect a blood sample at the time of the examination in order to obtain the woman's baseline genomic sequence. 3. De-identified samples will then have DNA and RNA extracted and whole genome sequencing and transcriptome analysis performed by Covance and Illumina. 4. Comparisons will be made within a breast (two ducts) and between the duct and blood as well as between women.

Key facts

Study ID

NCT02121873

Run by

Atossa Therapeutics, Inc.

People needed

6

Starts

2011-07-01

Expected to finish

2012-08-01

Last updated by the study team

2023-07-20

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• Be female
• Have at least one intact nipple
• If over 50, have had a normal mammogram within 12 months prior to the enrollment date
• Have a normal physical examination of the breast to be studied within 12 months prior to the enrollment date
• Be > 18 years of age
• Sign the informed consent form

You may not qualify if…

• Be currently pregnant or pregnant within the last 12 months
• Be currently lactating or lactated within the last 12 months
• Have received chemotherapy in the last 12 months
• Have had an abnormal mammogram within the last year
• Have had any subareolar or other surgery (papilloma resections, biopsies or fine needle aspirations) within 2 centimeters of the nipple (biopsies and fine needle aspirations >2 centimeters from the nipple are acceptable)
• Have active infections or inflammation in a breast to be studied
• Have a known allergy to lidocaine
• Be unwilling to sign informed consent

Where it is running

• Dr. Susan Love Research Foundation — Santa Monica, California, United States

Full record on ClinicalTrials.gov

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