Breast cancer, hereditary breast cancer
Conditions
Interventions
A onetime dose of 4 IE oxytocin nasal spray is administered prior to the nipple fluid aspiration (NFA) procedure. Nipple fluid is obtained through the use of a manual assisted vacuum-system. After sub
Sponsors
Vrienden UMC Utrecht
Eligibility
Inclusion criteria
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
Exclusion criteria: - Bilateral ablative breast surgery - Bilateral breast reduction with nipple graft - Pregnancy or lactation - Active breast infection - Disseminated breast cancer
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| - Predictive value of biomarkers in early breast cancer development, with a primary focus on miRNA. - To establish biomarker profiles in NAF, follow them in time and establish a correlation with breast cancer development. - 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
| Measure | Time frame |
|---|---|
| Secondary Objectives: - To assess discomfort, uncertainty and distress experienced by subjects. - 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. | — |
Contacts
Public ContactSusana Patuleia
UMC Utrecht
Outcome results
None listed