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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

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 - Early diagnosis of breast cancer

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON50271
Enrollment
200
Registered
2016-08-17
Start date
2017-01-26
Completion date
Unknown
Last updated
2025-03-24

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

Conditions

breast cancer breast carcinoma

Interventions

None listed

Sponsors

Universitair Medisch Centrum Utrecht
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Female age >=18 years histologically proven invasive breast carcinoma

Exclusion criteria

Exclusion criteria: Bilateral breast reduction with nipple graft Bilateral ablative breast surgery Pregnancy or lactation Active breast infection Having disseminated breast cancer

Design outcomes

Primary

MeasureTime frame
To compare microRNA expression in nipple fluid from the cancerous breast to microRNA expression in nipple fluid from the contralateral breast, the tumor material obtained at surgery and blood from the same patient.

Secondary

MeasureTime frame
To assess the microRNA expression levels in nipple fluid obtained just before treatment. This will be compared to the microRNA expression levels in nipple fluid already obtained from healthy controls.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)