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

Completed

• Conditions: breast cancer; breast malignancy; 10006291; 10006232

• Registration Number: NL-OMON47370
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 29 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 300

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

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>- To evaluate miRNA expression levels in NAF of healthy volunteers to determine<br /><br>a baseline that will lead to cutoff values for the detection of breast cancer.<br /><br>- Finding the best endogenous control for real-time quantitation of miRNAs in<br /><br>NAF.<br /><br>- To evaluate miRNA expression levels in blood of healthy volunteers to<br /><br>correlate the results in NAF to those in paired serum and/or plasma. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>- Evaluate the feasibility of performing RNA sequencing in NAF.<br /><br>- Evaluate exosome extraction from NAF and asses miRNAs in NAF-derived exosomes<br /><br>- To assess discomfort, uncertainty and distress experienced by subjects<br /><br>undergoing NFA by means of a questionnaire.</p><br>