Prevention of breast cancer in high risk women by monitoring microrna expression in nipple aspirate fluid.

Completed

• Conditions: breast cancer; breast carcinoma; 10083624; 10006291; 10006232

• Registration Number: NL-OMON44762
• Lead Sponsor: niversitair Medisch Centrum Utrecht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 18 June 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 720

Inclusion Criteria

- Germline BRCA1 or BRCA2 mutation
- A > 20% lifetime risk of developing breast cancer
- Previous DCIS/invasive breast cancer

Exclusion Criteria

-Bilateral ablative breast surgery
-Bilateral breast reduction with nipple graft
-Pregnancy or lactating
-Active breast infection
-Disseminated disease

Study & Design

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

Primary Outcome Measures

Name	Time	Method
<p>-Quantification of miRNA expression levels from nipple aspirate fluid samples<br /><br>collected annually.<br /><br>-Breast cancer development and their histological features.<br /><br>-Establishing a biobank of blood samples (plasma and serum) of women at<br /><br>increased breast cancer risk</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>-Discomfort, uncertainty and distress experienced because of and during<br /><br>procedure</p><br>