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

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

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON44762
Enrollment
720
Registered
2006-06-06
Start date
2008-08-07
Completion date
Unknown
Last updated
2024-06-18

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
-Quantification of miRNA expression levels from nipple aspirate fluid samples collected annually. -Breast cancer development and their histological features. -Establishing a biobank of blood samples (plasma and serum) of women at increased breast cancer risk

Secondary

MeasureTime frame
-Discomfort, uncertainty and distress experienced because of and during procedure

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)