To be able to assess the value of new markers, we first analyze these potential markers in nipple aspirate fluid and blood from healthy women. The main goal of this study is to evaluate the normal expression levels of microRNAs in NAF and blood to…
ID
Source
Brief title
Condition
- Breast neoplasms malignant and unspecified (incl nipple)
- Breast disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
- To evaluate miRNA expression levels in NAF of healthy volunteers to determine
a baseline that will lead to cutoff values for the detection of breast cancer.
- Finding the best endogenous control for real-time quantitation of miRNAs in
NAF.
- To evaluate miRNA expression levels in blood of healthy volunteers to
correlate the results in NAF to those in paired serum and/or plasma.
Secondary outcome
- Evaluate the feasibility of performing RNA sequencing in NAF.
- Evaluate exosome extraction from NAF and asses miRNAs in NAF-derived exosomes
- To assess discomfort, uncertainty and distress experienced by subjects
undergoing NFA by means of a questionnaire.
Background summary
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
in breast cancer development. Therefore, epigenetic monitoring, like aberrant
microRNA expression, could be a breakthrough in breast cancer prevention.
Diagnostically there is a need for better procedures that will predict
accurately who will and who will not develop breast cancer. In this project we
aim to assess miRNA expression in nipple aspirate fluid and blood in healthy
women.
Study objective
To be able to assess the value of new markers, we first analyze these potential
markers in nipple aspirate fluid and blood from healthy women. 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. We want to explore the feasibility of performing RNA sequencing in
NAF to identify new potential biomarkers in the future and we evaluate exosome
extraction from NAF and assess miRNAs in NAF-derived exosomes.
Study design
This study has a cross-sectional design and healthy women will be included.
Nipple fluid will be obtained one time and the women will not be followed in
time. A one time dose of 4 IE oxytocin nasal spray is administered prior to the
nipple aspiration procedure. Nipple fluid is obtained through use of a
vacuum-system. A questionnaire is filled out before and after the nipple fluid
aspiration procedure.
Study burden and risks
The data obtained in healthy volunteers will allow us to improve our program
that monitors development of epigenetic changes in nipple aspirates in women at
high risk for developing breast cancer to optimally time preventive breast
surgery. This will allow on one hand postponing or avoiding a mutilating
operation in these high risk women as much as possible (reducing morbidity),
while on the other hand preventing development of invasive breast cancer
(reducing mortality). Oxytocin-supported nipple aspiration is very well
tolerated as has been demonstrated in our previous study.
Heidelberglaan 100
Utrecht 3584 CX
NL
Heidelberglaan 100
Utrecht 3584 CX
NL
Listed location countries
Age
Inclusion criteria
- Female
- Healthy
- Non-lactating
- * 45 years
Exclusion criteria
- Male
- Age under 45 years
- Pregnancy or lactating
- Active breast infection
- Bilateral ablative breast surgery
- Bilateral breast reduction with nipple graft
- Personal history of DCIS or invasive breast cancer
- > 20% risk of developing breast cancer
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL41845.041.12 |