Evaluation of the OSNA method for the detection of lymph node metastases in women with endometrial cancer - A feasibility study
Recruiting
- Conditions
- C54.1Endometrium
- Registration Number
- DRKS00021520
- Lead Sponsor
- Sysmex Europe GmbH
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Female
- Target Recruitment
- 300
Inclusion Criteria
• After reviewing the patient information sheet, the patient's written consent must be given
• Patients with endometrial cancer who are undergoing SLNB
Exclusion Criteria
• Patients who are affected by other metastatic cancer
• Patients judged to be incapable of participating in the study by the investigator
• Patient choice
Study & Design
- Study Type
- observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method • Diagnostic sensitivity<br>• Diagnostic specificity<br>• Positive predictive value<br>• Negative predictive value<br>• Likelihood ratio<br>• Expected values in normal and affected populations<br><br>The endpoints are collected at the end of recruitment.
- Secondary Outcome Measures
Name Time Method • Concordance between OSNA and ultra-staging