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Non-invasive micro-RNA-based breast cancer diagnostics (Mammacheck)

Non-invasive micro-RNA-based breast cancer diagnostics (Mammacheck) - Mammacheck

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00023108
Enrollment
2500
Registered
2020-12-08
Start date
2020-10-20
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

healthy subjects C50.9

Interventions

Group 1: -determination of biomarkers (ncRNAs) from urine of women with breast cancer. -This requires a one-time urine collection from the patients. Group 2: -determination of biomarkers (ncRNAs) fr

Sponsors

Prof. Dr. Thalia ErbesUniversitätsklinikum FreiburgKlinik für Frauenheilkunde
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: patients: Confirmed diagnosis of a primary, non pretreated breast cancer - female sex - signed declaration of consent - >18 years old Comparison test subjects: - >18 years old - female sex - signed declaration of consent

Exclusion criteria

Exclusion criteria: Age: <18 years - Condition after breast cancer disease - Pregnancy - Acute infections Participation in a drug study within the last 3 months (exclusion by corresponding passage in the declaration of consent)

Design outcomes

Primary

MeasureTime frame
Determination of the precision of the developed non-invasive diagnostic procedure. endpoint: sensitivity, specificity relative to the reference (biopsy for tumor resection)

Secondary

MeasureTime frame
Determination of the significance of the developed non-invasive diagnostic procedure for the analyzed population. endpoint: positive predictive value, negative predictive value.

Countries

Germany

Contacts

Public ContactDaniela Weiß

Klinikum für FrauenheilkundeUniversitätsklinikum Freiburg

daniela.weiss@uniklinik-freiburg.de+4976127029750

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026