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Evaluation of the OSNA method for the detection of lymph node metastases in women with endometrial cancer - A feasibility study

Evaluation of the OSNA method for the detection of lymph node metastases in women with endometrial cancer - A feasibility study - CP-OSNA-EC-210

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00021520
Enrollment
300
Registered
2020-05-25
Start date
2020-09-01
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

C54.1

Interventions

Group 1: Women with endometrial cancer undergoing surgery whose sentinel lymph nodes will be analysed by both ultra-staging and OSNA.

Sponsors

Sysmex Europe GmbH
Lead Sponsor

Eligibility

Sex/Gender
Female
Age
18 Years to 99 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
• Diagnostic sensitivity • Diagnostic specificity • Positive predictive value • Negative predictive value • Likelihood ratio • Expected values in normal and affected populations The endpoints are collected at the end of recruitment.

Secondary

MeasureTime frame
• Concordance between OSNA and ultra-staging

Countries

Czechia, Hungary, Italy, Poland, Spain, United Kingdom

Contacts

Public ContactJan Kostun

University Hospital Pilsen

KOSTUNJ@fnplzen.cz+420 377 103 111

Outcome results

None listed

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