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NCT02121873 · ClinicalTrials.gov registry record
The Breast Duct: Pilot Study of Genomic Sequencing of Exfoliated Ductal Cells Obtained Through Endoscopy and Lavage
A clinical trial, sponsored by Atossa Therapeutics.
- Completed
- Registry status
- 6
- Enrollment target
NCT02121873 is a clinical trial that has completed, run by Atossa Therapeutics. The registered enrollment target is 6 participants.
The verdict
NCT02121873 has completed, sponsored by Atossa Therapeutics.
- COMPLETED
- Registry status
- 6 participants
- Enrollment target
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.
Interventions
- DEVICE Nipple aspirator
- DEVICE Ductal lavage microcatheter
- DEVICE Blood draw
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6 participants |
| Start Date | 2011-07 |
| Est. Completion | 2012-08 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02121873
The ClinicalTrials.gov registry entry for NCT02121873 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 6 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Atossa Therapeutics, which has 4 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Nipple aspirator is the first listed.
NCT02121873 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02121873 about?
NCT02121873 is a clinical study titled "The Breast Duct: Pilot Study of Genomic Sequencing of Exfoliated Ductal Cells Obtained Through Endoscopy and Lavage". 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 wom...
What is the current status of trial NCT02121873?
This trial is currently completed. The enrollment target is 6 participants. The study started on 2011-07. Estimated completion is 2012-08.
What interventions are being tested in trial NCT02121873?
The interventions under investigation include: Nipple aspirator (DEVICE), Ductal lavage microcatheter (DEVICE), Blood draw (DEVICE).
Who is sponsoring clinical trial NCT02121873?
This trial is sponsored by Atossa Therapeutics, which has 4 total clinical trials registered on ClinicalTrials.gov.
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