Early detection of Hereditary Breast Cancer by Monitoring MicroRNA expression in Nipple Aspirate Fluid
Recruiting
- Conditions
- Breast cancer, hereditary breast cancer
- Registration Number
- NL-OMON24687
- Lead Sponsor
- Vrienden UMC Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 620
Inclusion Criteria
> 20% lifetime risk of developing breast cancer (e.g. due to germline mutations such as BRCA1 or BRCA2)
- Previous DCIS/invasive breast cancer
- Female = 18 years of all ethnic backgrounds
Exclusion Criteria
- Bilateral ablative breast surgery
- Bilateral breast reduction with nipple graft
- Pregnancy or lactation
- Active breast infection
- Disseminated breast cancer
Study & Design
- Study Type
- Observational non invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method - Predictive value of biomarkers in early breast cancer development, with a primary focus on miRNA.<br>- To establish biomarker profiles in NAF, follow them in time and establish a correlation with breast cancer development.<br>- To determine threshold values of these biomarkers that point to a significant risk of imminent breast cancer development thereby indicating the right time of prophylactic breast surgery.
- Secondary Outcome Measures
Name Time Method Secondary Objectives:<br>- To assess discomfort, uncertainty and distress experienced by subjects.<br>- To set up a Biobank of blood samples and serum of women at increased breast cancer risk, providing opportunities to correlate molecular biomarker results in NAF to those in serum and/or plasma in the near future.