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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: Completed study, sponsored by Atossa Therapeutics.
NCT02121873 is a clinical trial that has completed, run by Atossa Therapeutics. The registered enrollment target is 6 participants. According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Extract high-quality DNA and RNA from human whole blood and ductal lavage (DL) samples. Assess QC and Quantitation of extracted RNA and DNA samples. Assess QC and Quantitation of libraries generated by CGL for Whole Genome DNA-seq and RNA sequencing assays. Sequence prepared libraries using the Illumina Next Generation Sequencing platform.
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 |
What the finished NCT02121873 record still lists
NCT02121873 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 6 participants, a relatively small participant target.
The record links to 0 conditions, and to 3 interventions - of which Nipple aspirator is the first listed.
NCT02121873 does not publish any study locations in the registry export this page uses.
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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