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

NCT02121873 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 6

Last updated 2023-07-20

No results posted yet for this study

Summary

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.

Conditions

  • Breast Cancer
  • Preneoplastic Conditions
  • Ductal Carcinoma in Situ

Interventions

DEVICE

Nipple aspirator

The subject will undergo nipple aspiration with a suction device designed to elicit fluid from the nipple.

DEVICE

Ductal lavage microcatheter

Upon completion of the nipple aspiration procedure, subjects will undergo a nipple block with local anesthesia. The duct will be lavaged with the ductal lavage microcatheter. Samples will be immediately processed for shipping to Covance for WGS. Subjects will be contacted 24 hours and again 2 weeks after the procedure to collect any untoward effects of participating in the study.

DEVICE

Blood draw

Blood will be drawn and immediately processed for shipping to Covance for WGS.

Sponsors & Collaborators

  • Covance

    collaborator INDUSTRY

  • Illumina, Inc.

    collaborator INDUSTRY

  • Atossa Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Dr. Susan Love, MD · The Dr. Susan Love Research Foundation

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-07-31
Primary Completion
2011-09-30
Completion
2012-08-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02121873 on ClinicalTrials.gov