Breast Cancer Biomarkers in Nipple Aspirate Fluid and Blood in Healthy Wome
Completed
- Conditions
- Breast cancer
- Registration Number
- NL-OMON24678
- Lead Sponsor
- Private sponsor and private foundation
- Brief Summary
Patuleia SIS, van Gils CH, Oneto Cao AM, Bakker MF, van Diest PJ, van der Wall E, Moelans CB. The Physiological MicroRNA Landscape in Nipple Aspirate Fluid: Differences and Similarities with Breast Tissue, Breast Milk, Plasma and Serum. Int J Mol Sci. 2020 Nov 11;21(22):8466. doi: 10.3390/ijms21228466. PMID: 33187146; PMCID: PMC7696615.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 187
Inclusion Criteria
Female
- Healthy
- Non-lactating
- Over the age of 45 years
Exclusion Criteria
- Male
- Age under 45 years
- Bilateral ablative breast surgery
- Bilateral breast reduction with nipple graft
- Pregnancy or lactation
- Active breast infection
- Personal history of DCIS or invasive breast cancer
- > 20% risk of developing breast cancer
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The main study parameters is the degree and patterns of microRNA expression in NAF and blood of healthy women, and to compare this with the pattern of women with breast cancer (ORNAMENT study, Trial NL6031)
- Secondary Outcome Measures
Name Time Method Secondary parameters are optimization of RNA sequencing in NAF and the assessment of miRNAs in NAF derived exosomes. In addition, we assess discomfort, uncertainty and distress experienced by subjects undergoing NFA.