C53.9
Conditions
Interventions
Group 1: Evaluation of sentinel lymph nodes with ultrastaging.
Sponsors
Sysmex Europe GmbH
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: For patients: • Women = 18 years of age • Written Patient consent must be given following review of the Patient Information Sheet For diseases: • Cervical cancer patients undergoing SLNB (choice of stages to be included is at the discretion of the study site)
Exclusion criteria
Exclusion criteria: Exclusion criteria: • Women < 18 years of age • Patients who are affected by other metastatic cancer • Patients who were affected in the past by other malignancies • Pregnant women • Patients who withdrew their consent to participate to the study or did not gave their consent to participate to study • Patients who underwent chemo- or radio-therapy before surgery • HIV-positive patients • Patients judged to be incapable of participating in the study by the investigator • Patients having a known allergy to tracer/s used for SLNB • Patient choice
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The clinical performance of the OSNA method will be determined by assessment of: - Diagnostic sensitivity - Diagnostic specificity - Positive predictive value - Negative predictive value - Likelihood ratio - Expected values in normal and affected populations | — |
Secondary
| Measure | Time frame |
|---|---|
| Moreover, the concordance rate between the OSNA method and ultra-staging will be calculated, as well as the ability of both tests in differentiating between no metastasis, micro- (from 0.2 to 2 mm), macro-metastases (greater than 2 mm) and isolated tumour cells (ITCs). | — |
Countries
Czechia, Italy, Poland, Spain
Contacts
Public ContactIsabel Guerra Merino
Centro Sanitario Hospital Universitario Araba
Outcome results
None listed