No registrations found.
ID
Source
Health condition
Breast cancer
Sponsors and support
Intervention
Outcome measures
Primary outcome
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
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.
Background summary
Rationale: Breast cancer develops by the stepwise accumulation of interacting epigenetic and genetic events over time. While genetic events are specific processes that differ greatly between patients, epigenetic events are more generally occurring during breast cancer development. Therefore, epigenetic monitoring (in addition to genetic monitoring) could become a breakthrough in breast cancer prevention. Diagnostically there is a need for better procedures that can predict accurately who will and who will not develop breast cancer. Circulating miRNAs can be easily measured in body fluids such as nipple aspirate fluid (NAF) and blood, which could offer a promising minimally invasive method to complement current breast cancer screening methods. This study is part of a larger project that aims to assess the microRNA expression levels in NAF and blood of women with recently diagnosed breast cancer. Those expression levels will be compared to those obtained in this healthy control study. The results from this project will be further validated in a nested case-control study (NAF study). The ultimate goal is to develop a tool that enables a more accurate early prediction of the onset of breast cancer, to monitor development of microRNA expression patterns in NAF and blood of women at high risk for breast cancer.
Objective: The main goal of this study is to evaluate the normal expression levels of microRNAs in NAF and blood to determine baselines that will lead to cut-off values for the detection of breast cancer. The results will be compared with microRNA levels obtained just before primary surgery from patients with suspicion of, or histologically proven, breast cancer. We will perform stability analysis of candidate endogenous controls, and choose a microRNA that then can be used as endogenous control for real-time quantitation of miRNAs in NAF and blood in healthy subjects, women at high risk of developing breast cancer and breast cancer patients.
Study design: This study has a cross-sectional design and healthy women will be included. NAF and blood will be obtained once and the women will not be followed over time.
Study objective
The main goal of this study is to evaluate the normal expression levels of microRNAs in NAF and blood to determine baselines that will lead to cut-off values for the detection of breast cancer. The results will be compared with microRNA levels obtained just before primary surgery from patients with suspicion of, or histologically proven, breast cancer. We will perform stability analysis of candidate endogenous controls, and choose a microRNA that then can be used as endogenous control for real-time quantitation of miRNAs in NAF and blood in healthy subjects, women at high risk of developing breast cancer and breast cancer patients.
Study design
Not applicable
Intervention
A onetime dose of 4 IE oxytocin nasal spray is administered prior to the nipple fluid aspiration (NFA) procedure. NAF is obtained through the use of a manual vacuum-system. In addition, three vials of blood will be taken
Susana Patuleia
+31887557409 (Office manager of the Principal Investigator)
s.i.schoutenpatuleia-7@umcutrecht.nl
Susana Patuleia
+31887557409 (Office manager of the Principal Investigator)
s.i.schoutenpatuleia-7@umcutrecht.nl
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
Design
Recruitment
IPD sharing statement
Followed up by the following (possibly more current) registration
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Other (possibly less up-to-date) registrations in this register
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In other registers
| Register | ID |
|---|---|
| NTR-new | NL8987 |
| Other | METC UMCU : METC 12-495 |