Clinical trial · Observational
The Breast Duct: Pilot Study of Genomic Sequencing of Exfoliated Ductal Cells Obtained Through Endoscopy and Lavage
NCT02121873CI-TRIAL-00068130completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Ductal Carcinoma in Situ | Breast Ductal Carcinoma In Situ | ALIAS | 0.90 |
| Preneoplastic Conditions | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Blood draw | Device | — | UNRESOLVED |
| Ductal lavage microcatheter | Device | — | UNRESOLVED |
| Nipple aspirator | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Women with and without breast cancer
- description
- Nipple aspirator, ductal lavage microcatheter, blood draw
- interventionNames
- Device: Nipple aspirator
- Device: Ductal lavage microcatheter
- Device: Blood draw
Primary outcomes (1)
- measure
- Identify early epithelial somatic mutations/indels in precancerous breast ducts by comparing genetic DNA sequences from cells obtained from venous blood and ductal lavage
- timeFrame
- At six months
- description
- 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.
Secondary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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
References
Publications (5)
- BACKGROUNDMahoney ME, Gordon EJ, Rao JY, Jin Y, Hylton N, Love SM. Intraductal therapy of ductal carcinoma in situ: a presurgery study. Clin Breast Cancer. 2013 Aug;13(4):280-6. doi: 10.1016/j.clbc.2013.02.002. Epub 2013 May 9. PMID 23664819
- BACKGROUNDLove SM, Zhang W, Gordon EJ, Rao J, Yang H, Li J, Zhang B, Wang X, Chen G, Zhang B. A feasibility study of the intraductal administration of chemotherapy. Cancer Prev Res (Phila). 2013 Jan;6(1):51-8. doi: 10.1158/1940-6207.CAPR-12-0228. Epub 2012 Nov 20. PMID 23169924
- BACKGROUNDMannello F, Ligi D. Resolving breast cancer heterogeneity by searching reliable protein cancer biomarkers in the breast fluid secretome. BMC Cancer. 2013 Jul 12;13:344. doi: 10.1186/1471-2407-13-344. PMID 23849048
- BACKGROUNDMa CX, Ellis MJ. The Cancer Genome Atlas: clinical applications for breast cancer. Oncology (Williston Park). 2013 Dec;27(12):1263-9, 1274-9. PMID 24624545
- BACKGROUNDKaur H, Mao S, Shah S, Gorski DH, Krawetz SA, Sloane BF, Mattingly RR. Next-generation sequencing: a powerful tool for the discovery of molecular markers in breast ductal carcinoma in situ. Expert Rev Mol Diagn. 2013 Mar;13(2):151-65. doi: 10.1586/erm.13.4. PMID 23477556