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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Observational

Source

NL-OMON

Registry ID

NL-OMON47370

Enrollment

300

Registered

2013-02-20

Start date

2013-05-21

Completion date

Unknown

Last updated

2024-04-29

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

Conditions

breast cancer breast malignancy

Interventions

None listed

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - Female - Healthy - Non-lactating - * 45 years

Exclusion criteria

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 outcomes

Primary

Measure	Time frame
- 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

Measure	Time frame
- 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.	—

Countries

Netherlands

Outcome results