- Assess the feasibility of the nipple aspiration procedure- Gain experience in methods and techniques of nipple aspiration - Identify factors that are associated with the fluid yielding status of nonlactating women- Assess the discomfort…
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
- Percentage of fluid yielding breasts
- Volume of nipple fluid that is obtained
- Number (concentration) of epithelial cells per fluid sample
Secondary outcome
Discomfort experienced by participants
Background summary
Breast cancer is the leading cause of cancer death in women in the Western
world. Most breast carcinomas arise in the ductal epithelial, the so called
target tissue. Monitoring changes in the epithelial cells could lead to a
breakthrough in breast cancer screening and prevention. Nipple fluid (that
contains epithelial breast cells) can be obtained from nonlactating women in a
non-invasive way with a vacuum suction system. This pilot is part of a project
that aims to set up a program to monitor development of methylation patterns in
nipple aspirates of women at high risk for breast cancer. Such a program would
on one hand postpone or avoid a mutilating operation (reduce morbidity) and on
the other hand prevent development of invasive breast cancer (reduce
mortality).
Study objective
- Assess the feasibility of the nipple aspiration procedure
- Gain experience in methods and techniques of nipple aspiration
- Identify factors that are associated with the fluid yielding status of
nonlactating women
- Assess the discomfort experienced by women undergoing the procedure
Study design
Nipple aspiration will be performed in 30 women after nasal administration of
oxytocin through use of a vacuum-system. A short questionnaire will be
presented to the subject before and after the procedure.
Study burden and risks
Nipple aspiration (using nasal oxytocin) has been very well tolerated in prior
studies; even better than mammography. Risks for participants are low.
Theoretically, hematoma or mastitis could occur, but these effects appear to be
low in previous studies. Oxytocin could cause painful aching as is experienced
during breast feeding by some women.
Postbus 85500
3508 GA Utrecht
Nederland
Postbus 85500
3508 GA Utrecht
Nederland
Listed location countries
Age
Inclusion criteria
non lactating women
Exclusion criteria
pregnancy, active breast infection, bilateral ablative breast surgery, breast surgery that disrupts breast tissue, personal of family history of 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 | NL11698.041.06 |