Breast Cancer Biomarkers in Nipple Aspirate Fluid and Blood in Healthy Women

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON24678

Enrollment

187

Registered

2020-10-16

Start date

2017-10-10

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast cancer

Interventions

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

Eligibility

Inclusion criteria

Inclusion criteria: - Female - Healthy - Non-lactating - Over the age of 45 years

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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.	—

Contacts

Public ContactSusana Patuleia

UMC Utrecht

s.i.schoutenpatuleia-7@umcutrecht.nl+31887557409 (Office manager of the Principal Investigator)

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)