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

• Conditions: healthy subjects; C50.9; Breast, unspecified

• Registration Number: DRKS00023108
• Lead Sponsor: Prof. Dr. Thalia ErbesUniversitätsklinikum FreiburgKlinik für Frauenheilkunde

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 2004

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

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)

Study & Design

• Study Type: observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Determination of the precision of the developed non-invasive diagnostic procedure.<br>endpoint:<br>sensitivity, specificity relative to the reference (biopsy for tumor resection)

Secondary Outcome Measures

Name	Time	Method
Determination of the significance of the developed non-invasive diagnostic procedure for the analyzed population.<br>endpoint:<br>positive predictive value, negative predictive value.