Early diagnosis of breast cancer: A multicenter, crOss sectional, study to assess microRNA expression in Nipple Aspirate Fluid, blood and tuMor material in women with primary brEast caNcer compared with healthy conTrols The ORNAMENT study
Completed
- Conditions
- breast cancerbreast carcinoma10006291
- Registration Number
- NL-OMON50271
- Lead Sponsor
- niversitair Medisch Centrum Utrecht
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 200
Inclusion Criteria
Female age >=18 years
histologically proven invasive breast carcinoma
Exclusion Criteria
Bilateral breast reduction with nipple graft
Bilateral ablative breast surgery
Pregnancy or lactation
Active breast infection
Having disseminated breast cancer
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To compare microRNA expression in nipple fluid from the cancerous breast to<br /><br>microRNA expression in nipple fluid from the contralateral breast, the tumor<br /><br>material obtained at surgery and blood from the same patient. </p><br>
- Secondary Outcome Measures
Name Time Method <p>To assess the microRNA expression levels in nipple fluid obtained just before<br /><br>treatment. This will be compared to the microRNA expression levels in nipple<br /><br>fluid already obtained from healthy controls.</p><br>