No registrations found.
Source
Brief title
Health condition
Breast cancer, hereditary breast cancer
Sponsors and support
Intervention
No registrations found.
Outcome measures
Primary outcome
- 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 outcome
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.
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 in breast cancer development. Therefore, epigenetic monitoring (in addition to genetic monitoring) 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. MicroRNAs (miRNAs) are small, non-protein-coding RNAs (~18-25 nucleotides in length) that regulate gene expression on a post-transcriptional level by binding to and thereby suppressing specific target mRNAs. In this project we aim to assess the occurrence and changes over time of miRNA expression levels in NAF of women at high risk for breast cancer to determine risks and correct timing of interventions. The current evidence indicates that miRNAs, present in all human body fluids, have the potential to act as biomarkers of malignancy, as they show high accuracy in identifying different tumor types. With that in mind, we are in the process of establishing a Biobank of blood samples of women at increased breast cancer risk to be able to determine the usefulness of biomarkers in blood, and their correlation with results from NAF.
Objective: To establish biomarkers in NAF, follow them in time and link them to breast cancer development at its earliest stage in women at high risk for breast cancer. Threshold values of biomarkers will be determined that point to a significant risk of imminent breast cancer development, thereby indicating the right time of prophylactic breast surgery in these high-risk women.
Study objective
Predictive value of biomarkers in early breast cancer development, with a primary focus on miRNA.
Study design
0, 6 months, 12 months, 18 months before disease onset
Intervention
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 subject’s approval, three vials of blood for biobanking will be taken.
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
Design
Recruitment
IPD sharing statement
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 |
---|---|
NTR-new | NL8661 |
Other | METC UMC Utrecht : METC 06-091 (CCMO: NL11690.041.06) |